IPS
- Primary DI
- 00888118128232
- Brand
- IPS
- Company
- KLS-Martin L.P.
- Model
- 60-002-40-09
- Device description
- IMPLANT, MIDFACE, COMPLEX, TI-6AL-4V
- Published
- 2020-06-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JEY | Plate, Bone | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888118128232 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00888118128232 | 00888118128232 | 888118128232 | 0888118128232 |
GMDN Terms
| Term | Definition |
|---|
| Cranial bone prosthesis, custom-made | A sterile 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 |
Regulatory Flags
- DUNS number
- 826499238
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00888118149671 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149701 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149718 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149725 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149732 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149749 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149756 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149763 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149770 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149787 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149794 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149800 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149817 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149824 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149831 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149848 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149855 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149879 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149886 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149893 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149909 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149916 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149923 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149930 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149947 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149954 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149961 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149978 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149985 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118153128 | LEVEL ONE NEURO, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
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