SMR Shoulder
- Primary DI
- 08033390095211
- Brand
- SMR Shoulder
- Company
- LIMACORPORATE SPA
- Model
- Compactor Handle
- Catalog number
- 9013.75.370
- Device description
- Compactor Handle
- Published
- 2016-04-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08033390095211 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08033390095211 | 08033390095211 | 8033390095211 |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument handle, non-torque-limiting | A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 432066322
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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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