Intended purpose of use: Catheter intended for surgical programmes in case of ureter trauma. The device is mostly used for ureter dilation, bypass of partial obstructions, upper urinary tract drainage/irrigation during surgery, stone removal, of for retrograde urography etc
Product description:
A flexible tube designed for introduction into the ureters. It is a radiopaque tube with a straight tip configuration.
Complete radio opaque for X ray visualization. Single lumen
Marking at every cm and double marking at every 5cm.
Two eyes for efficient drainage.
Catheter with adapter and stylet.
A luer lock adaptor is provided at proximal end of the catheter for fitting to syringe.
With guide wire.
Diameter expressed in Charriere, French gauge.
Length expressed in cm.
Colour code cup connector.
Material: Polyvinyl chloride (PVC), Polyurethane of silicone. May be coated to reduce friction.
Size selected:
Diameter CH6
Length: 70cm
Sterile, Single use.
Shelf life 3 years minimum
Instructions for use:
As per manufacturer's instruction for use
Safety process:
When inserting a urethral catheter, use strict aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Indications for use, contraindications, warnings, storage and disposal etc.
Packaging and labelling: Packaging and labelling shall be as per regulations applied to the device.
Primary packaging: Unit of use
One Ureteric catheter in an individual sterilised peel pack.
Symbols used according ISO 15223
CE Mark and Notified Body number
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 IIb device
Safety & product Standards (must be as per latest revisions of the standards):
Must comply with the following standards:
ISO 20697 : Sterile drainage catheters and accessory devices for single use
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Environmental requirements: ISO 14001
Product description:
A flexible tube designed for introduction into the ureters. It is a radiopaque tube with a straight tip configuration.
Complete radio opaque for X ray visualization. Single lumen
Marking at every cm and double marking at every 5cm.
Two eyes for efficient drainage.
Catheter with adapter and stylet.
A luer lock adaptor is provided at proximal end of the catheter for fitting to syringe.
With guide wire.
Diameter expressed in Charriere, French gauge.
Length expressed in cm.
Colour code cup connector.
Material: Polyvinyl chloride (PVC), Polyurethane of silicone. May be coated to reduce friction.
Size selected:
Diameter CH6
Length: 70cm
Sterile, Single use.
Shelf life 3 years minimum
Instructions for use:
As per manufacturer's instruction for use
Safety process:
When inserting a urethral catheter, use strict aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Indications for use, contraindications, warnings, storage and disposal etc.
Packaging and labelling: Packaging and labelling shall be as per regulations applied to the device.
Primary packaging: Unit of use
One Ureteric catheter in an individual sterilised peel pack.
Symbols used according ISO 15223
CE Mark and Notified Body number
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 IIb device
Safety & product Standards (must be as per latest revisions of the standards):
Must comply with the following standards:
ISO 20697 : Sterile drainage catheters and accessory devices for single use
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Environmental requirements: ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $9.99 |
| Pack of 10 | $35.51 |
