MULTI-GUIDE
- Primary DI
- 34546540259074
- Brand
- MULTI-GUIDE
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 62-20023
- Catalog number
- 62-20023
- Device description
- SELF-DRILLING PINS, AUTO PILOT
- Published
- 2015-09-24
- 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 |
|---|---|---|---|---|
| 34546540259074 | Primary | GS1 | 0 | |
| 04546540259073 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 34546540259074 | 34546540259074 | |
| 04546540259073 | 04546540259073 | 4546540259073 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 15 | Millimeter |
| Length | 90 | Millimeter |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 2
- 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 |
|---|---|---|---|---|
| 04546540364883 | NA | 50-12900 | 50-12900 | 2023-02-13 |
| 07613327369489 | AXS | 62-12178 | 62-12178 | 2019-09-11 |
| 04546540246332 | NA | 60-10104 | 60-10104 | 2016-08-24 |
| 04546540246356 | NA | 60-10108 | 60-10108 | 2016-08-24 |
| 04546540246387 | NA | 60-10112 | 60-10112 | 2016-08-24 |
| 04546540256805 | NA | 62-00534 | 62-00534 | 2016-10-19 |
| 04546540258991 | NA | 62-17401 | 62-17401 | 2016-10-19 |
| 04546540274175 | NA | 64-00105 | 64-00105 | 2016-12-08 |
| 04546540274250 | NA | 64-00132 | 64-00132 | 2017-01-11 |
| 04546540356758 | NA | 64-00242 | 64-00242 | 2016-12-08 |
| 04546540356765 | NA | 64-00243 | 64-00243 | 2016-12-08 |
| 04546540366467 | NA | 60-09504 | 60-09504 | 2016-08-24 |
| 04546540366481 | NA | 60-10512 | 60-10512 | 2016-08-24 |
| 04546540366498 | NA | 60-13506 | 60-13506 | 2016-08-24 |
| 04546540366504 | NA | 60-13512 | 60-13512 | 2016-08-24 |
| 04546540366511 | NA | 60-13570 | 60-13570 | 2016-08-24 |
| 04546540366672 | NA | 62-12173 | 62-12173 | 2017-01-11 |
| 04546540366689 | NA | 62-12175 | 62-12175 | 2017-01-11 |
| 04546540366696 | NA | 62-12176 | 62-12176 | 2017-01-11 |
| 04546540366702 | NA | 62-17517 | 62-17517 | 2016-10-19 |
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 |