Coptos Th

FDA UDI

Class II (US FDA UDI)

by Soc Etudes Recherches Fabrication

Identity

Trade Name: COPTOS TH FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: NOVAE Dual Mobility Acetabular Cup - COPTOS TH revision metal-back cementless COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook) FDA UDI
Model / Reference: COPTOS 71 TH FDA UDI
Description: NOVAE Dual Mobility Acetabular Cup - COPTOS TH revision metal-back cementless COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook) FDA UDI

Identifiers

Primary DI / UDI-DI: 03662200005666 FDA UDI
FDA Product Code: MEH FDA UDI
LZO FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Acetabular shell

Coptos Th by Soc Etudes Recherches Fabrication — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Soc Etudes Recherches Fabrication

Sources (1)

FDA UDI d9221ac8-dd9f-4b2e-8aab-3e8622e5ff97 33 fields · synced Jun 1, 2026