MULTI-GUIDE
- Primary DI
- 34546540259067
- Brand
- MULTI-GUIDE
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 62-20022
- Catalog number
- 62-20022
- 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 |
|---|---|---|---|---|
| 34546540259067 | Primary | GS1 | 0 | |
| 04546540259066 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 34546540259067 | 34546540259067 | |
| 04546540259066 | 04546540259066 | 4546540259066 |
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 | 10 | Millimeter |
| Length | 90 | Millimeter |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 2
- DM exempt
- true
- 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 |
|---|---|---|---|---|
| 07613327300086 | NA | 78-80020 | 78-80020 | 2021-01-27 |
| 07613327300109 | NA | 78-80040 | 78-80040 | 2021-01-27 |
| 07613327300123 | NA | 78-80030 | 78-80030 | 2021-01-27 |
| 04546540730763 | NA | 78-10010 | 78-10010 | 2015-07-03 |
| 04546540730787 | NA | 78-10030 | 78-10030 | 2015-07-03 |
| 04546540730794 | NA | 78-10040 | 78-10040 | 2015-07-03 |
| 04546540730800 | NA | 78-10100 | 78-10100 | 2015-07-03 |
| 07613327004021 | NA | 78-10020 | 78-10020 | 2015-07-03 |
| 07613327129236 | NA | 78-40010 | 78-40010 | 2015-09-24 |
| 07613327129243 | NA | 78-40100 | 78-40100 | 2015-09-24 |
| 07613327129250 | NA | 78-40040 | 78-40040 | 2015-09-24 |
| 07613327129267 | NA | 78-50030 | 78-50030 | 2015-09-24 |
| 07613327129274 | NA | 78-50040 | 78-50040 | 2015-09-24 |
| 07613327129281 | NA | 78-50020 | 78-50020 | 2015-09-24 |
| 07613327129298 | NA | 78-40030 | 78-40030 | 2015-09-24 |
| 07613327129328 | NA | 78-50010 | 78-50010 | 2015-09-24 |
| 07613327129335 | NA | 78-40020 | 78-40020 | 2015-09-24 |
| 07613327300017 | NA | 78-70020 | 78-70020 | 2017-02-21 |
| 07613327300031 | NA | 78-70040 | 78-70040 | 2017-02-21 |
| 07613327300055 | NA | 78-70030 | 78-70030 | 2017-02-21 |
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 |