OsteoMed
- Primary DI
- 00845694032759
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 217-1210
- Catalog number
- 217-1210
- Device description
- Distraction Tool, Short
- Published
- 2016-07-25
- 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 |
|---|
| 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 |
|---|
| 00845694032759 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694032759 | 00845694032759 | 845694032759 | 0845694032759 |
GMDN Terms
| Term | Definition |
|---|
| General internal orthopaedic fixation system implantation kit | A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store at a controlled room temperature between 15ºC to 30ºC (59ºF to 86ºF). |
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 |
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