FDA UDI
In Commercial Distribution
🇺🇸 United States
COPAL® knee mould Trial M US
DI: 04260102139329
·
Model: M
·
Heraeus Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- COPAL® knee mould Trial M US
- Primary DI
- 04260102139329
- Version / Model
- M
- Catalog Number
- 5165923
- Company Name
- Heraeus Medical GmbH
- Labeler DUNS
- 333623937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-25
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- a27a8643-b40f-4c93-8360-fd078370971c
Device Description
COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWT | Template | Orthopedic | 888.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63524 | Knee revision 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 intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260102139336 | GS1 | Carton | 15 | In Commercial Distribution | |
| Primary | 04260102139329 | GS1 | ||||
| Package | 04260102139343 | GS1 | Pallet | 270 | In Commercial Distribution |