COPAL® exchange G
- Primary DI
- 04260102133044
- Brand
- COPAL® exchange G
- Company
- Heraeus Medical GmbH
- Model
- Trial Set knee
- Catalog number
- 5092607
- Device 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.
- Published
- 2020-07-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HWT | Template |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWT | Template | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260102130609 | Package | GS1 | 15 | In Commercial Distribution |
| 04260102131156 | Package | GS1 | 210 | In Commercial Distribution |
| 04260102133044 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260102130609 | 04260102130609 | 4260102130609 |
| 04260102131156 | 04260102131156 | 4260102131156 |
| 04260102133044 | 04260102133044 | 4260102133044 |
GMDN Terms#
| Term | Definition |
|---|---|
| Knee revision femur/tibia prosthesis trial | A copy of a final knee revision prosthesis, in the form of combined femoral and tibial components, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device. |
Regulatory Flags#
- DUNS number
- 333623937
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04260102139329 | COPAL® knee mould Trial M US | M | 5165923 | 2023-06-25 |
| 04260102139350 | COPAL® knee mould Trial L US | L | 5165924 | 2023-06-25 |
| 04260102139381 | COPAL® knee mould Trial S US | S | 5159874 | 2023-06-25 |
| 04260102139411 | OSTEOPAL® | V | 5130982 | 2025-09-26 |
| 04260102139428 | OSTEOPAL® | V | 5130982 | 2025-09-26 |
| 04260102139855 | COPAL® G+V | 1x40 | 5184267 | 2024-06-10 |
| 04260102139862 | COPAL® G+V | 1x40 | 5184267 | 2024-06-10 |
| 04260102136670 | COPAL® exchange G | hip S long | 5034792 | 2019-11-25 |
| 04260102136700 | COPAL® exchange G | hip M long | 5034790 | 2019-11-25 |
| 04260102136731 | COPAL® exchange G | hip L long | 5034785 | 2019-11-25 |
| 04260102136762 | COPAL® exchange G | hip XL long | 5034794 | 2019-11-25 |
| 04260102136793 | COPAL® exchange G | hip S short | 5034793 | 2019-11-25 |
| 04260102136823 | COPAL® exchange G | hip M short | 5034791 | 2019-11-25 |
| 04260102136854 | COPAL® exchange G | hip L short | 5034788 | 2019-11-25 |
| 04260102139176 | COPAL® exchange G | hip S medium | 5147215 | 2022-05-15 |
| 04260102139206 | COPAL® exchange G | hip M medium | 5147216 | 2022-05-15 |
| 04260102136885 | COPAL® exchange G | hip XL short | 5034795 | 2019-11-25 |
| 04260102136694 | COPAL® exchange G | hip S long | 5034792 | 2019-11-25 |
| 04260102136724 | COPAL® exchange G | hip M long | 5034790 | 2019-11-25 |
| 04260102136755 | COPAL® exchange G | hip L long | 5034785 | 2019-11-25 |
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