DISTRACTION, EXTERNAL
- Primary DI
- 10888118082289
- Brand
- DISTRACTION, EXTERNAL
- Company
- KLS-Martin L.P.
- Model
- 51-575-12-09
- Device description
- SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM
- Published
- 2016-03-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
klsmartin.comProduct Codes#
| Code | Name |
|---|---|
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MQN | External Mandibular Fixator And/Or Distractor | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10888118082289 | Primary | GS1 | 0 | |
| 00888118082282 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10888118082289 | 10888118082289 | ||
| 00888118082282 | 00888118082282 | 888118082282 | 0888118082282 |
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 |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
Regulatory Flags#
- DUNS number
- 826499238
- Device count
- 10
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00888118126528 | LEVEL ONE CMF, STERILE | 50-774-24-71 | 2020-04-22 | |
| 00888118006530 | LEVEL ONE CMF | 01-405-08-09 | 2016-03-24 | |
| 00888118034717 | LEVEL ONE CMF | 25-001-13-09 | 2016-03-24 | |
| 00888118034731 | LEVEL ONE CMF | 25-002-13-09 | 2016-03-24 | |
| 00888118034748 | LEVEL ONE CMF | 25-003-02-09 | 2016-03-24 | |
| 00888118034816 | LEVEL ONE NEURO, STERILE | 25-003-10-71 | 2016-03-23 | |
| 00888118034915 | LEVEL ONE NEURO | 25-003-21-09 | 2016-03-24 | |
| 00888118035028 | LEVEL ONE NEURO | 25-005-12-09 | 2016-03-24 | |
| 00888118035042 | LEVEL ONE CMF | 25-006-09-09 | 2016-03-24 | |
| 00888118035721 | LEVEL ONE CMF | 25-010-03-09 | 2016-03-24 | |
| 00888118035752 | LEVEL ONE CMF | 25-010-08-09 | 2016-03-24 | |
| 00888118035882 | LEVEL ONE NEURO | 25-015-04-09 | 2016-03-24 | |
| 00888118035912 | LEVEL ONE NEURO | 25-015-06-09 | 2016-03-24 | |
| 00888118035943 | LEVEL ONE NEURO | 25-015-08-09 | 2016-03-24 | |
| 00888118035974 | LEVEL ONE NEURO | 25-016-06-09 | 2016-03-24 | |
| 00888118036018 | LEVEL ONE NEURO | 25-016-10-09 | 2016-03-24 | |
| 00888118036049 | LEVEL ONE CMF | 25-017-04-09 | 2016-03-24 | |
| 00888118036056 | LEVEL ONE CMF | 25-017-06-09 | 2016-03-24 | |
| 00888118036063 | LEVEL ONE CMF | 25-017-08-09 | 2016-03-24 | |
| 00888118036148 | LEVEL ONE CMF | 25-020-24-09 | 2016-03-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00888118108685 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2017-08-17 |
| 00888118006189 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118006202 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118006226 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118007261 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118007278 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118032812 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037480 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037503 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037510 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118039439 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118039446 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044457 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044471 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044495 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044518 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044532 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044556 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044631 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044655 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044679 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045010 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045034 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045058 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045072 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045096 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045119 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045133 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045195 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045485 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |