Intended purpose of use: to measure the pelvis externally.
Product description:
Collyer Pelvimeter, use to measure the pelvis externally.
Material: Austenitic stainless steel
composition: 16 - 18% chromium, 10 - 14% nickel and 2 -3% molybdenum.
Graduation in centimetres and inches, maximum width
Width of jaws approx.: 300 - 500 mm.
Instructions for use:
Device used for measuring the pelvis externally.
Packaging & Labelling:
One (1) Pelvimeter + Information for user
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 Im device
Safety & product Standards:
Must comply with following standards
IS0 13485: 2016
ISO 10993-1:2009
Environmental requirements:
ISO 14001
Product description:
Collyer Pelvimeter, use to measure the pelvis externally.
Material: Austenitic stainless steel
composition: 16 - 18% chromium, 10 - 14% nickel and 2 -3% molybdenum.
Graduation in centimetres and inches, maximum width
Width of jaws approx.: 300 - 500 mm.
Instructions for use:
Device used for measuring the pelvis externally.
Packaging & Labelling:
One (1) Pelvimeter + Information for user
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 Im device
Safety & product Standards:
Must comply with following standards
IS0 13485: 2016
ISO 10993-1:2009
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $28.80 |
