OsteoMed
- Primary DI
- 00845694032742
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 217-1230
- Catalog number
- 217-1230
- Device description
- Oracle 1.5mm Spacer
- 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
- false
- 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 |
|---|
| 00845694032742 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694032742 | 00845694032742 | 845694032742 | 0845694032742 |
GMDN Terms
| Term | Definition |
|---|
| Implantable craniofacial bone distractor | An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation. |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 1.3 | 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
| 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 |
osteomed.com