COPAL® exchange G

FDA UDI

Class II (US FDA UDI)

by Heraeus Medical LLC

Identity

Trade Name: COPAL® exchange G FDA UDI
Generic Name: Orthopaedic cement spacer FDA UDI
Device Name: COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). FDA UDI
Model / Reference: hip L long FDA UDI
Description: COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). FDA UDI

Identifiers

Catalog Number: 5034785 FDA UDI
Primary DI / UDI-DI: 04260102136731 FDA UDI
FDA Product Code: KWL FDA UDI
KWY FDA UDI
GMDN Term: Orthopaedic cement spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3360 FDA UDI
888.3390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

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

MRI Safety

MR Safe FDA UDI

Category: Orthopaedic cement spacer

COPAL® exchange G by Heraeus Medical LLC — 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: Heraeus Medical LLC

Sources (1)

FDA UDI 0344cb61-15ba-4e71-9da7-2fb83dafdf5b 34 fields · synced May 30, 2026