NA
- Primary DI
- 07613252133742
- Brand
- NA
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 62-00435
- Catalog number
- 62-00435
- Device description
- INTERNAL MIDFACE DISTRACTOR, 35MM
- Published
- 2015-10-09
- 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 |
|---|
| 07613252133742 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07613252133742 | 07613252133742 | 7613252133742 |
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 |
|---|
| Length | 35 | Millimeter |
| Length | 68 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 316153956
- 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
- 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 |
|---|
| 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 |