Tornier Perform
- Primary DI
- 00846832092192
- Brand
- Tornier Perform
- Company
- TORNIER, INC.
- Model
- DWM003A
- Catalog number
- DWM003A
- Device description
- US Anatomic Nucleus
- Published
- 2022-09-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| PKC | Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00846832092192 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846832092192 | 00846832092192 | 846832092192 | 0846832092192 |
GMDN Terms
| Term | Definition |
|---|
| Trabeculated shoulder humeral stem prosthesis | A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and has a convoluted/perforated surface intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is typically intended to be performed without bone cement. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 968990812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- 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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| 03701037321041 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321058 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321065 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321072 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321089 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321096 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
| 03701037321102 | FX V135 | FX SOLUTIONS | PKC | 2025-02-20 |
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| 00889024678743 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678750 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678767 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678774 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678781 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678798 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678804 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678811 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678828 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678835 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678842 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678859 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678866 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678873 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678880 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |
| 00889024678897 | OsseoFit™ Stemless Shoulder | Zimmer, Inc. | PKC | 2024-12-18 |