NA
- Primary DI
- 04546540257703
- Brand
- NA
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 62-01025
- Catalog number
- 62-01025
- Device description
- PIN CLAMP, LEFT
- Published
- 2015-07-07
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product 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 |
|---|---|
| K960297 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04546540257703 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04546540257703 | 04546540257703 | 4546540257703 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone pin, non-bioabsorbable | A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327097627 | CranialMask Tracker | 6000-390-000 | 6000-390-000 | 2017-03-13 |
| 07613327499711 | N/A | 8900-200-200 | 8900-200-200 | 2023-03-23 |
| 07613327551938 | N/A | 6002-710-050 | 6002-710-050 | 2022-07-26 |
| 07613327620306 | N/A | 6002-810-500 | 6002-810-500 | 2025-10-28 |
| 07613327616118 | N/A | 6002-810-000 | 6002-810-000 | 2024-08-22 |
| 07613327616255 | N/A | 6002-810-300 | 6002-810-300 | 2024-08-15 |
| 07613327616286 | N/A | 81-81044 | 81-81044 | 2024-08-15 |
| 07613327638189 | N/A | 6002-810-100 | 6002-810-100 | 2024-08-15 |
| 07613327638196 | N/A | 6002-810-200 | 6002-810-200 | 2024-08-15 |
| 07613327579833 | N/A | 700001577582 | 700001577582 | 2024-08-07 |
| 07613327576542 | N/A | 8800-100-000 | 8800-100-000 | 2023-04-11 |
| 07613327500530 | N/A | 8000-060-019 | 8000-060-019 | 2023-03-24 |
| 07613327500615 | N/A | 8000-060-016 | 8000-060-016 | 2023-03-23 |
| 07613327500622 | N/A | 8000-060-014 | 8000-060-014 | 2023-03-23 |
| 07613327500639 | N/A | 8000-060-015 | 8000-060-015 | 2023-03-23 |
| 07613327500646 | N/A | 8000-060-018 | 8000-060-018 | 2023-03-23 |
| 07613327538328 | Cranial Guidance Software | 81-81042 | 81-81042 | 2023-03-23 |
| 07613327538410 | Cranial Guidance Software | 6000-670-300 | 6000-670-300 | 2023-03-23 |
| 07613327500509 | N/A | 8000-040-017 | 8000-040-017 | 2023-03-22 |
| 07613327500523 | N/A | 8000-040-018 | 8000-040-018 | 2023-03-22 |
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 |