Intended purpose of use: to temporarily compress the umbilical cord immediately after birth. It is used before cutting of ligating the cord, and is intended to enable aseptic haemostasis.
Product description:
Disposable sterile umbilical cord clamp, safe, effective and easy to apply.
Safe security lock, with a click to indicate correct locking, to protect against accidental re-opening after clamping.
Grooves all along the length to prevent slip of the umbilical cord and to retain it in the same position.
Finger grip to ensure safe and easy handling.
Measurements: approx. 52 mm
Material: Plastic (polymer) medical grade. DEHP free & latex free
Single-use.
Sterile
Supplied with:
Manufacturer's instruction for use
Instructions for use:
Disposable sterile umbilical cord clamp, safe, effective and easy to apply, designed for clamping the umbilical cord soon after the birth
CE mark and reference number of notifying body.
Packaging & Labelling:
One (1) umbilical cord clamp in an individual sterilised peel pack.
Symbols used according ISO 15223 and EN 15986:2011
CE mark and reference number of notifying body.
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 (as per the latest revisions of the standard):
ISO 11135 - Sterilization of health-care products
ISO 11607-1:2018, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-7
Environmental requirements:
ISO 14001
Product description:
Disposable sterile umbilical cord clamp, safe, effective and easy to apply.
Safe security lock, with a click to indicate correct locking, to protect against accidental re-opening after clamping.
Grooves all along the length to prevent slip of the umbilical cord and to retain it in the same position.
Finger grip to ensure safe and easy handling.
Measurements: approx. 52 mm
Material: Plastic (polymer) medical grade. DEHP free & latex free
Single-use.
Sterile
Supplied with:
Manufacturer's instruction for use
Instructions for use:
Disposable sterile umbilical cord clamp, safe, effective and easy to apply, designed for clamping the umbilical cord soon after the birth
CE mark and reference number of notifying body.
Packaging & Labelling:
One (1) umbilical cord clamp in an individual sterilised peel pack.
Symbols used according ISO 15223 and EN 15986:2011
CE mark and reference number of notifying body.
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 (as per the latest revisions of the standard):
ISO 11135 - Sterilization of health-care products
ISO 11607-1:2018, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-7
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.06 |
| Pack of 50 | $2.84 |
| Pack of 100 | $5.82 |
