EXTERNAL DISTRACTION SYSTEM
- Primary DI
- 00841036057428
- Brand
- EXTERNAL DISTRACTION SYSTEM
- Company
- BIOMET MICROFIXATION, INC
- Model
- 99-3581
- Catalog number
- 99-3581
- Published
- 2015-10-11
- 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#
zimmerbiomet.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 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K992952 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841036057428 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841036057428 | 00841036057428 | 841036057428 | 0841036057428 |
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. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(904)741-4400 | FXJAX-ORDERS@ZIMMERBIOMET.COM |
Regulatory Flags#
- DUNS number
- 046189866
- Device count
- 1
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00888233085021 | PECTUS BLU (TM) | 78-8200 | 78-8200 | 2026-01-27 |
| 00888233085038 | PECTUS BLU (TM) | 78-8250 | 78-8250 | 2026-01-27 |
| 00810128536875 | PECTUS BLU (TM) | 78-8500 | 78-8500 | 2024-09-30 |
| 00888233077170 | PECTUS BLU (TM) | 78-8000 | 78-8000 | 2024-09-30 |
| 00888233077187 | PECTUS BLU (TM) | 78-8080 | 78-8080 | 2024-09-30 |
| 00888233077194 | PECTUS BLU (TM) | 78-8081 | 78-8081 | 2024-09-30 |
| 00888233077200 | PECTUS BLU (TM) | 78-8082 | 78-8082 | 2024-09-30 |
| 00888233077224 | PECTUS BLU (TM) | 78-8300 | 78-8300 | 2024-09-30 |
| 00888233077231 | PECTUS BLU (TM) | 78-8350 | 78-8350 | 2024-09-30 |
| 00888233077248 | PECTUS BLU (TM) | 78-8400 | 78-8400 | 2024-09-30 |
| 00888233077255 | PECTUS BLU (TM) | 78-8450 | 78-8450 | 2024-09-30 |
| 00888233077279 | PECTUS BLU (TM) | 78-8550 | 78-8550 | 2024-09-30 |
| 00888233028776 | PECTUS BLU (TM) | 78-0010 | 78-0010 | 2022-02-09 |
| 00888233028783 | PECTUS BLU (TM) | 78-0011 | 78-0011 | 2022-02-09 |
| 00888233028790 | PECTUS BLU (TM) | 78-0012 | 78-0012 | 2022-02-09 |
| 00888233028806 | PECTUS BLU (TM) | 78-0020 | 78-0020 | 2022-02-09 |
| 00888233028813 | PECTUS BLU (TM) | 78-0030 | 78-0030 | 2022-02-09 |
| 00888233028837 | PECTUS BLU (TM) | 78-0040 | 78-0040 | 2022-02-09 |
| 00888233028844 | PECTUS BLU (TM) | 78-0050 | 78-0050 | 2022-02-09 |
| 00888233028851 | PECTUS BLU (TM) | 78-0051 | 78-0051 | 2022-02-09 |
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 |