ACUMED
- Primary DI
- 10806378031007
- Brand
- ACUMED
- Company
- Acumed LLC
- Model
- 5101-0412R
- Device description
- ARH Slide-Loc™ Trial Long Stem 12mm, RT
- Published
- 2015-10-24
- 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 |
|---|
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10806378031007 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10806378031007 | 10806378031007 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 196884852
- 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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| 00850005618577 | BioPoly® Radial Head Implant | Biopoly, LLC | KWI | 2025-01-02 |
| 00850005618584 | BioPoly® Radial Head Implant | Biopoly, LLC | KWI | 2025-01-02 |
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| 00850005618614 | BioPoly® Radial Head Implant | Biopoly, LLC | KWI | 2025-01-02 |
| 00850005618621 | BioPoly® Radial Head Implant | Biopoly, LLC | KWI | 2025-01-02 |
| 00850005618638 | BioPoly® Radial Head Implant | Biopoly, LLC | KWI | 2025-01-02 |
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