Enztec Patella Shim - 2mm
- Primary DI
- 09421028111201
- Brand
- Enztec Patella Shim - 2mm
- Company
- ENZTEC LIMITED
- Model
- 4240-4302
- Catalog number
- 4240-4302
- Device description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
- Published
- 2022-06-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09421028111201 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09421028111201 | 09421028111201 | 9421028111201 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic prosthesis implantation instrument, reusable | A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 592616445
- Device count
- 1
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
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| 09421038412305 | Offset coupling, AO | 9209-1313 | 9209-1313 | 2026-03-09 |
| 09421038412312 | Cup reamer handle, offset, AO, open | 9209-1312 | 9209-1312 | 2026-03-09 |
| 09421038412329 | Offset drive train, open | 9209-1304 | 9209-1304 | 2026-03-09 |
| 09421038412671 | Cup reamer handle, offset, Z/H, open | 9209-1302 | 9209-1302 | 2026-03-09 |
| 09421038411865 | Enztec Modular OCI X | 4251-3101 | 4251-3101 | 2026-02-27 |
| 09421038411889 | Adj Dist Fem Alignment Guide – Cartilage | 4240-7700 | 4240-7700 | 2026-02-27 |
| 09421038411896 | Adj Dist Fem Alignment Guide – Paddle | 4240-7701 | 4240-7701 | 2026-02-27 |
| 09421038411902 | Sagittal Alignment Connector - Pivot | 4240-7705 | 4240-7705 | 2026-02-27 |
| 09421038411919 | Sagittal Alignment Connector - Pivot with Fan | 4240-7706 | 4240-7706 | 2026-02-27 |
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| 09421038411940 | Dist Fem Cut Block Connector – 10mm | 4240-7712 | 4240-7712 | 2026-02-27 |
| 09421038411957 | Dist Fem Cut Block Slot Connector – 8mm | 4240-7725 | 4240-7725 | 2026-02-27 |
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