IPS
- Primary DI
- 00888118129727
- Brand
- IPS
- Company
- KLS-Martin L.P.
- Model
- 60-008-81-09
- Device description
- DIST, ORAL/MAX, ZURICH 2, END DRV, LARGE, CP TITANIUM
- Published
- 2022-10-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
klsmartin.comProduct 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 |
|---|---|---|---|---|
| 00888118129727 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00888118129727 | 00888118129727 | 888118129727 | 0888118129727 |
GMDN Terms#
| Term | Definition |
|---|---|
| Custom-made cranial bone prosthesis | An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
Regulatory Flags#
- DUNS number
- 826499238
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00888118149244 | L1 THORACIC | CTM-24-015-84-04 | 2026-05-01 | |
| 00888118149251 | L1 CMF | CTM-55-911-83-04 | 2026-05-01 | |
| 00888118149268 | L1 CMF | CTM-55-911-84-04 | 2026-05-01 | |
| 00888118149275 | L1 CMF | CTM-55-911-85-04 | 2026-05-01 | |
| 00888118149282 | L1 CMF | CTM-55-911-86-04 | 2026-05-01 | |
| 00888118149299 | L1 CMF | CTM-55-911-87-04 | 2026-05-01 | |
| 00888118149305 | L1 CMF | CTM-55-911-88-04 | 2026-05-01 | |
| 00888118149312 | L1 CMF | CTM-55-911-89-04 | 2026-05-01 | |
| 00888118149329 | L1 CMF | CTM-55-911-90-04 | 2026-05-01 | |
| 00888118126528 | LEVEL ONE CMF, STERILE | 50-774-24-71 | 2020-04-22 | |
| 00888118006530 | LEVEL ONE CMF | 01-405-08-09 | 2016-03-24 | |
| 00888118034717 | LEVEL ONE CMF | 25-001-13-09 | 2016-03-24 | |
| 00888118034731 | LEVEL ONE CMF | 25-002-13-09 | 2016-03-24 | |
| 00888118034748 | LEVEL ONE CMF | 25-003-02-09 | 2016-03-24 | |
| 00888118034816 | LEVEL ONE NEURO, STERILE | 25-003-10-71 | 2016-03-23 | |
| 00888118034915 | LEVEL ONE NEURO | 25-003-21-09 | 2016-03-24 | |
| 00888118035028 | LEVEL ONE NEURO | 25-005-12-09 | 2016-03-24 | |
| 00888118035042 | LEVEL ONE CMF | 25-006-09-09 | 2016-03-24 | |
| 00888118035721 | LEVEL ONE CMF | 25-010-03-09 | 2016-03-24 | |
| 00888118035752 | LEVEL ONE CMF | 25-010-08-09 | 2016-03-24 |
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 |