OsteoMed
- Primary DI
- 00845694044950
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 218-3040-SP
- Catalog number
- 218-3040-SP
- Device description
- SmartFlex Spring - Small - 4N
- Published
- 2015-04-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| PBJ | Cranial Distraction System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PBJ | Cranial Distraction System | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00845694044950 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694044950 | 00845694044950 | 845694044950 | 0845694044950 |
GMDN Terms
| Term | Definition |
|---|
| Cranioplasty plate, alterable | An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00888118149367 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2025-09-24 |
| 00888118136589 | DISTRACTION, INTERNAL | KLS-Martin L.P. | PBJ | 2023-12-25 |
| 00888118136596 | DISTRACTION, INTERNAL | KLS-Martin L.P. | PBJ | 2023-12-25 |
| 00888118136626 | DISTRACTION, INTERNAL | KLS-Martin L.P. | PBJ | 2023-12-25 |
| 00888118136633 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2023-12-25 |
| 00888118136640 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2023-12-25 |
| 00888118136657 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2023-12-25 |
| H98004315852010 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315784010 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315788010 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315792010 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315806010 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315824050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315832050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315786050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315788050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315790050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315804050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315846050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315850050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315808050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| H98004315810050 | NA | SYNTHES (U.S.A.) LP | PBJ | 2019-12-12 |
| 00842528123300 | OsteoMed | OSTEOMED LLC | PBJ | 2019-11-08 |
| 00842528123317 | OsteoMed | OSTEOMED LLC | PBJ | 2019-11-08 |
| 00888118114310 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
| 00888118114464 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
| 00888118114471 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
| 00888118114488 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
| 00888118114495 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
| 00888118114501 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | PBJ | 2018-01-12 |
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