Intended purpose of use: thin, non-adhesive cotton tape for the tying of umbilical cords.
Product description:
Roll of thread is used as a ligature thread to tie the umbilical cord.
Non-absorbable.
Braided and flat.
Material: 100% cotton.
Width: approximately 3 mm.
Length: approximately 50m.
Non-sterile and single use.
Hygienically packed for medical use.
Instructions for use:
Umbilical tape is used as a ligature thread to tie the umbilical cord.
To prevent cutting of damage to the umbilical cord: do not select monofilament, round of thin ligature threads.
Select cotton to prevent untying of knots.
This item can be subjected to steam sterilising.
The size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) umbilical tape in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) umbilical tapes in a box.
Symbols used according ISO 15223.
CE Mark.
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 I device.
Safety & product Standards:
Must comply with the following standards ( must comply to latest revisions of the standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
Product description:
Roll of thread is used as a ligature thread to tie the umbilical cord.
Non-absorbable.
Braided and flat.
Material: 100% cotton.
Width: approximately 3 mm.
Length: approximately 50m.
Non-sterile and single use.
Hygienically packed for medical use.
Instructions for use:
Umbilical tape is used as a ligature thread to tie the umbilical cord.
To prevent cutting of damage to the umbilical cord: do not select monofilament, round of thin ligature threads.
Select cotton to prevent untying of knots.
This item can be subjected to steam sterilising.
The size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) umbilical tape in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) umbilical tapes in a box.
Symbols used according ISO 15223.
CE Mark.
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 I device.
Safety & product Standards:
Must comply with the following standards ( must comply to latest revisions of the standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.75 |
| Pack of 200 | $336.00 |
