Identity
- Trade Name
- COPAL® exchange G FDA UDI
- Generic Name
- Hip revision prosthesis trial FDA UDI
- Device Name
- COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin. FDA UDI
- Model / Reference
- Trial Set hip XL FDA UDI
- Description
- COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin. FDA UDI
Identifiers
- Catalog Number
- 5097415 FDA UDI
- Primary DI / UDI-DI
- 04260102130593 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Hip revision prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hip revision prosthesis trial
COPAL® exchange G by Heraeus Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip revision prosthesis trial.
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial shaft — ADLER ORTHO SPA · Class I
- Synicem Hip Spacer Trial Case (marked) Regular — BIOCOMPOSITES LTD · Class I
- Trial stem — ADLER ORTHO SPA · Class I
- Synicem 56C Hip Trial FDA — BIOCOMPOSITES LTD · Class I
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial collar — ADLER ORTHO SPA · Class I
- Synicem 48M Hip Trial FDA — BIOCOMPOSITES LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (1)
- FDA UDI 086fe073-33ca-4299-8bc2-20435bc9e655 34 fields · synced Jun 8, 2026