IMPORTANT NOTE:
These technical specs are generic & may vary depending on Supplier.
Needle w/base (Luer type fitting) & protective cap. Material: Needle - stainless steel. Base & protective cap - Medical grade plastic. Sterile, single-use (ethylene oxide sterilisation).
External diameter expressed in gauge & millimeters. Length expressed preferably in millimetres. Size: 25 G (0.5 x 25mm). Non-toxic. Pyrogen free.
Cannula & tube: Made of stainless steel. Normal & thin walled. Long bevelled (angle inferior or equal to 13°) or short bevelled (angle between 13° and 19°).
Silicone coated to facilitate insertion. Base: Allows needle to be connected to syringe/other injection devices. Formed by conical female Luer connection.
Prevents needle from rolling on flat surface. Made of polypropene (PP). Internationally recognized colour code system allows easy identification of hypodermic needle's external diameter. Cap: protects cannula & its bevel, & preserves sterility of needle. Made polypropylene (PP).
Supplied with: Manufacturer’s instructions for use may be printed onto primary packaging or provided on separate insert.
Languages: Eng, Spa & Fre.
Accessories (available but not supplied): N/A
Intended use: For subcutaneous or intramuscular (SC,IM) injection: adults, For intravenous (IV) injection: children, For intramuscular (IM) injection: children, infants, For intra-arterial: adults, children
Safety process: needle is for single use only. When inserting needle: use aseptic techniques. Packaging & Labelling: Primary packaging: Unit of use. One (1) needle packed in individ. sterilised peel pack made of paper &/or plastic. Secondary packaging: Protected unit.
One (1) Box of hundred (100) blister packed needles.
Primary package label includes: Device identity & intended purpose.
Manufacturer's product code or reference number. Manufacturer identification.
Address of manufacturing site.
EC Rep identification.
How dice should be used, maintained & stored.
Lot/Batch & MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used ISO 15223. CE mark.
Word "sterile" (or equiv. harmonised symbol).
Sterilisation method (or equiv. harmonised symbol).
Words "for single use" (or equiv. harmonised symbol).
Words "check the package integrity before use", or similar warning.
Words "dispose after use", if space allows.
Secondary package label includes number of units.
Regulation and Conformity Requirements: CE mark (conforming to MD Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050. ISO 13485.
Classification: Class IIa sterile (MDD 93/42/EEC, MDR 2017/745)
Safety & Product Standards (current versions):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
ISO 11607-1: Packaging for Terminally sterilized MDs - Part 1 : Requirements for materials, sterile barrier systems & packaging systems.
ISO 11607-2: Packaging for terminally sterilized MDs — Part 2: Validation requirements for forming, sealing & assembly processes.
ISO 6009: Hypodermic needles for single use - Colour coding for identification.
ISO 7864: Sterile hypodermic needles for single use.
ISO 80369-1: Small-bore connectors for liquids & gases in healthcare applications — Part 1: Gel requirements.
ISO 80369-7: Small-bore connectors for liquids & gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications.
ISO 23908: Sharps injury protection - Requirements & test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters & needles used for blood sampling.
ISO 9626-1: Stainless steel needle tubing for manufacture of MDs — Requirements & test methods.
ISO 10993-1: Biological evaluation of MDs- Part : Evaluation & testing within a risk management process.
Environmental Requirements: Use of other polymer instead of PVC. ISO 14001: Environmental management
These technical specs are generic & may vary depending on Supplier.
Needle w/base (Luer type fitting) & protective cap. Material: Needle - stainless steel. Base & protective cap - Medical grade plastic. Sterile, single-use (ethylene oxide sterilisation).
External diameter expressed in gauge & millimeters. Length expressed preferably in millimetres. Size: 25 G (0.5 x 25mm). Non-toxic. Pyrogen free.
Cannula & tube: Made of stainless steel. Normal & thin walled. Long bevelled (angle inferior or equal to 13°) or short bevelled (angle between 13° and 19°).
Silicone coated to facilitate insertion. Base: Allows needle to be connected to syringe/other injection devices. Formed by conical female Luer connection.
Prevents needle from rolling on flat surface. Made of polypropene (PP). Internationally recognized colour code system allows easy identification of hypodermic needle's external diameter. Cap: protects cannula & its bevel, & preserves sterility of needle. Made polypropylene (PP).
Supplied with: Manufacturer’s instructions for use may be printed onto primary packaging or provided on separate insert.
Languages: Eng, Spa & Fre.
Accessories (available but not supplied): N/A
Intended use: For subcutaneous or intramuscular (SC,IM) injection: adults, For intravenous (IV) injection: children, For intramuscular (IM) injection: children, infants, For intra-arterial: adults, children
Safety process: needle is for single use only. When inserting needle: use aseptic techniques. Packaging & Labelling: Primary packaging: Unit of use. One (1) needle packed in individ. sterilised peel pack made of paper &/or plastic. Secondary packaging: Protected unit.
One (1) Box of hundred (100) blister packed needles.
Primary package label includes: Device identity & intended purpose.
Manufacturer's product code or reference number. Manufacturer identification.
Address of manufacturing site.
EC Rep identification.
How dice should be used, maintained & stored.
Lot/Batch & MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used ISO 15223. CE mark.
Word "sterile" (or equiv. harmonised symbol).
Sterilisation method (or equiv. harmonised symbol).
Words "for single use" (or equiv. harmonised symbol).
Words "check the package integrity before use", or similar warning.
Words "dispose after use", if space allows.
Secondary package label includes number of units.
Regulation and Conformity Requirements: CE mark (conforming to MD Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050. ISO 13485.
Classification: Class IIa sterile (MDD 93/42/EEC, MDR 2017/745)
Safety & Product Standards (current versions):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
ISO 11607-1: Packaging for Terminally sterilized MDs - Part 1 : Requirements for materials, sterile barrier systems & packaging systems.
ISO 11607-2: Packaging for terminally sterilized MDs — Part 2: Validation requirements for forming, sealing & assembly processes.
ISO 6009: Hypodermic needles for single use - Colour coding for identification.
ISO 7864: Sterile hypodermic needles for single use.
ISO 80369-1: Small-bore connectors for liquids & gases in healthcare applications — Part 1: Gel requirements.
ISO 80369-7: Small-bore connectors for liquids & gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications.
ISO 23908: Sharps injury protection - Requirements & test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters & needles used for blood sampling.
ISO 9626-1: Stainless steel needle tubing for manufacture of MDs — Requirements & test methods.
ISO 10993-1: Biological evaluation of MDs- Part : Evaluation & testing within a risk management process.
Environmental Requirements: Use of other polymer instead of PVC. ISO 14001: Environmental management
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $1.34 |
