OsteoMed
- Primary DI
- 00845694091213
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 303-1210
- Catalog number
- 303-1210
- Device description
- 1.2mm x 10mm Fully Threaded Screw
- Published
- 2015-10-06
- 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
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JEY | Plate, Bone | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00845694091213 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694091213 | 00845694091213 | 845694091213 | 0845694091213 |
GMDN Terms
| Term | Definition |
|---|
| Craniofacial bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 10 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 606417780
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 00888118149671 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149701 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149718 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149725 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149732 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149749 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149756 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149763 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149770 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149787 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149794 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149800 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149817 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149824 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149831 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149848 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149855 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149879 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149886 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149893 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149909 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149916 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149923 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149930 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149947 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149954 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149961 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149978 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149985 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118153128 | LEVEL ONE NEURO, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
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