NA
- Primary DI
- 10887587010076
- Brand
- NA
- Company
- Synthes GmbH
- Model
- 03.307.001
- Catalog number
- 03307001
- Device description
- WIRE FIXATION CLAMP FOR EXTERNAL MIDFACE DISTRACTOR
- Published
- 2015-09-14
- 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#
xx.xxProduct 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 |
|---|---|
| K040083 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10887587010076 | Primary | GS1 | 0 | |
| H980033070010 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10887587010076 | 10887587010076 |
GMDN Terms#
| Term | Definition |
|---|---|
| Craniofacial bone distractor extension | A partially-implantable device intended to be temporarily used as an extension for an implanted or partially-implanted craniofacial distractor allowing connection to the central adjustment thread of the distractor when its location is made difficult to access due to its surgical positioning. It is used to allow the required rotation of the thread in order to distract (force apart) the two bone surfaces of the mandibular body (the lower jawbone) during the adjustment period. It is typically made of high-grade stainless steel and may be rigid or flexible in design. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)255-2500 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 486711679
- Device count
- 1
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10705034712307 | NA | 03.604.002 | 03604002 | 2016-12-31 |
| 10705034712802 | NA | 03.606.011 | 03606011 | 2016-12-31 |
| 10705034714592 | NA | 03.613.012 | 03613012 | 2016-12-31 |
| 10705034767819 | VentroFix | 304.834 | 304834 | 2016-12-31 |
| 10705034768939 | NA | 314.064 | 314064 | 2016-12-31 |
| 10705034768960 | Click'X | 314.067 | 314067 | 2016-12-31 |
| 10705034768977 | Click'X | 314.068 | 314068 | 2016-12-31 |
| 10705034768984 | Click'X | 314.069 | 314069 | 2016-12-31 |
| 10705034769646 | NA | 328.026 | 328026 | 2016-12-31 |
| 10705034772608 | NA | 388.364 | 388364 | 2016-12-31 |
| 10705034775401 | NA | 389.288 | 389288 | 2016-12-31 |
| 10705034777375 | NA | 394.585 | 394585 | 2016-12-31 |
| 20705034764051 | NA | 292.020 | 292020 | 2019-08-29 |
| 00863176000317 | FIBULINK | FGS-1100 | FGS1100 | 2020-03-26 |
| 00863176000324 | FIBULINK | FGS-1300 | FGS1300 | 2020-03-26 |
| 00863176000300 | FIBULINK | FGS-1000 | FGS1000 | 2017-06-08 |
| 10886982113078 | NA | 04.130.260S | 04130260S | 2016-03-15 |
| 10886982077868 | NA | 03.311.010 | 03311010 | 2015-09-14 |
| 10886982077875 | NA | 03.311.011 | 03311011 | 2015-09-14 |
| 10886982077882 | NA | 03.311.012 | 03311012 | 2015-09-14 |
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 |