NA
- Primary DI
- 20845854018795
- Brand
- NA
- Company
- Conmed Corporation
- Model
- C9054
- Catalog number
- C9054
- Device description
- SE™ Graft Tensioner Breakaway Pins with Graft Tensioner Calculator
- Published
- 2021-10-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20845854018795 | Package | GS1 | 1 | In Commercial Distribution |
| 10845854018798 | Primary | GS1 | 0 | |
| 00845854018791 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 20845854018795 | 20845854018795 | | |
| 10845854018798 | 10845854018798 | | |
| 00845854018791 | 00845854018791 | 845854018791 | 0845854018791 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic bone pin, non-bioabsorbable | A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device. |
Regulatory Flags
- DUNS number
- 071595540
- Device count
- 5
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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