NA
- Primary DI
- H679395600
- Brand
- NA
- Company
- Synthes GmbH
- Model
- 395.60
- Catalog number
- 39560
- Device description
- 4.0MM CARBON FIBER ROD 60MM
- Published
- 2015-09-14
- 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
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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10886982200419 | Primary | GS1 | 0 | |
| H679395600 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10886982200419 | 10886982200419 |
GMDN Terms#
| Term | Definition |
|---|---|
| External orthopaedic fixation system, reusable | An assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device. |
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
- 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
- false
- 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#
| 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 |