MIS Crest Widener
- Primary DI
- 07290108994582
- Brand
- MIS Crest Widener
- Company
- MIS Implants Technologies Ltd.
- Model
- MK-CW28
- Device description
- MIS Crest widener kit
- Published
- 2016-09-22
- 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
Related Records
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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07290108994582 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07290108994582 | 07290108994582 | 7290108994582 |
GMDN Terms
| Term | Definition |
|---|---|
| Implantable craniofacial bone distractor | An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 514576057
- 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
- true
- 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 |
|---|---|---|---|---|
| 07290118501541 | MIS kit | MK-C051 | 2026-01-20 | |
| 07290118501558 | MIS kit | MK-CCXD | 2026-01-20 | |
| 07290118505044 | MIS kit | MG-K008 | 2026-01-20 | |
| 07290118505051 | MIS kit | MG-KD08 | 2026-01-20 | |
| 07290118505068 | MIS kit | MG-KT08 | 2026-01-20 | |
| 07290118505075 | MIS kit | MG-K009 | 2026-01-20 | |
| 07290118505099 | MIS kit | MK-0066 | 2026-01-20 | |
| 07290118505464 | MIS LYNX | LNXC-06420 | 2026-01-20 | |
| 07290118505471 | MIS LYNX | LNXC-06500 | 2026-01-20 | |
| 07290118505938 | MIS C1 | C1-X08375 | 2026-01-20 | |
| 07290118505945 | MIS C1 | C1C-X08375 | 2026-01-20 | |
| 07290118505952 | MIS C1 | C1-X10375 | 2026-01-20 | |
| 07290118505969 | MIS C1 | C1C-X10375 | 2026-01-20 | |
| 07290118505976 | MIS C1 | C1-X11375 | 2026-01-20 | |
| 07290118505983 | MIS C1 | C1C-X11375 | 2026-01-20 | |
| 07290118505990 | MIS C1 | C1-X13375 | 2026-01-20 | |
| 07290118506003 | MIS C1 | C1C-X13375 | 2026-01-20 | |
| 07290118506010 | MIS C1 | C1-X16375 | 2026-01-20 | |
| 07290118506027 | MIS C1 | C1C-X16375 | 2026-01-20 | |
| 07290118506034 | MIS C1 | C1-X10330 | 2026-01-20 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07613327682717 | NA | Stryker Leibinger GmbH & Co. KG | MQN | 2026-02-27 |
| 07613327682724 | NA | Stryker Leibinger GmbH & Co. KG | MQN | 2026-02-27 |
| 00888118145376 | IPS | KLS-Martin L.P. | MQN | 2025-09-24 |
| 00888118145383 | IPS | KLS-Martin L.P. | MQN | 2025-09-24 |
| 00888118145390 | IPS | KLS-Martin L.P. | MQN | 2025-09-24 |
| 00888118148735 | DISTRACTION, INTERNAL | KLS-Martin L.P. | MQN | 2025-09-24 |
| 00888118143457 | DISTRACTION, INTERNAL | KLS-Martin L.P. | MQN | 2025-02-24 |
| 00888118139962 | DISTRACTION, INTERNAL | KLS-Martin L.P. | MQN | 2023-02-23 |
| 00888118129611 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129628 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129635 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129642 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129659 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129666 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129673 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129680 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129697 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129703 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129710 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129727 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129734 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129741 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129758 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129765 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129772 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129789 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129796 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129802 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129819 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |
| 00888118129826 | IPS | KLS-Martin L.P. | MQN | 2022-10-21 |