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:
1/2 circle suture needle, round cross section with spring eye.
Suture needle size 14 of equivalent.
Sterile, Single use
Material: stainless steel, martensitic.
Shelf life to be included
Method of sterilization: it should be able to withstand autoclave of steam sterilization.
Supplied with:
Manufacturer's instruction for use. Indications for use, storage conditions, disposal instructions, precautions for use etc
Packaging and labelling: Shall be as per regulations applied to the device.
Unit packing: Individually packed in sterile peel packs
One (1) box of 12 suture needles.
Symbols used according ISO 15223
CE mark with 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 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:
1/2 circle suture needle, round cross section with spring eye.
Suture needle size 14 of equivalent.
Sterile, Single use
Material: stainless steel, martensitic.
Shelf life to be included
Method of sterilization: it should be able to withstand autoclave of steam sterilization.
Supplied with:
Manufacturer's instruction for use. Indications for use, storage conditions, disposal instructions, precautions for use etc
Packaging and labelling: Shall be as per regulations applied to the device.
Unit packing: Individually packed in sterile peel packs
One (1) box of 12 suture needles.
Symbols used according ISO 15223
CE mark with 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 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 12 | $6.38 |
| Pack of 24 | $30.00 |
