IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Used for the obstetric fistulas repairs
Product description:
Surgical Needle, stainless steel, sterile, 1/2 circle.
Material: hardened high-quality stainless steel (AISI 420/420+)
Size: 1.00 x 27mm, spring eye, needle and tip round bodied, for skin and muscle suturing.
Sterile and single use. Shelf life to be included
Initial sterilisation method: Ethylene oxide gas.
Packaging and labelling: shall be as per regulations applied to the device
One (1) suture needle in individual sterile packaging.
Box of twelve (12) needles.
CE mark with Notified Body number.
Symbols used according ISO 15223.
Markings Sterile and Single use, of equivalent symbols with Notified Body number.
Method of sterilization.
Lot, manufacturing and expiry date.
Manufacturer name and address.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class IIa device
Safety & product Standards:
Must comply with the following standards (must be compliant as per the latest revisions of standards):
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1:2009 Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process
ISO 13402 Surgical and dental hand instruments — Determination of resistance against autoclaving,
corrosion and thermal exposure
ASTM F3014 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
ASTM F1874 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Used for the obstetric fistulas repairs
Product description:
Surgical Needle, stainless steel, sterile, 1/2 circle.
Material: hardened high-quality stainless steel (AISI 420/420+)
Size: 1.00 x 27mm, spring eye, needle and tip round bodied, for skin and muscle suturing.
Sterile and single use. Shelf life to be included
Initial sterilisation method: Ethylene oxide gas.
Packaging and labelling: shall be as per regulations applied to the device
One (1) suture needle in individual sterile packaging.
Box of twelve (12) needles.
CE mark with Notified Body number.
Symbols used according ISO 15223.
Markings Sterile and Single use, of equivalent symbols with Notified Body number.
Method of sterilization.
Lot, manufacturing and expiry date.
Manufacturer name and address.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class IIa device
Safety & product Standards:
Must comply with the following standards (must be compliant as per the latest revisions of standards):
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1:2009 Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process
ISO 13402 Surgical and dental hand instruments — Determination of resistance against autoclaving,
corrosion and thermal exposure
ASTM F3014 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
ASTM F1874 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 24 | $17.56 |
