LEVEL ONE CMF
- Primary DI
- 00888118044136
- Brand
- LEVEL ONE CMF
- Company
- KLS-Martin L.P.
- Model
- 25-669-07-91
- Device description
- SCREW, CENTREDRIVE, DRILL FREE, TI-6AL-4V
- Published
- 2016-03-24
- 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
Product Codes
| Code | Name |
|---|
| HRS | Plate, fixation, bone |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888118044136 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00888118044136 | 00888118044136 | 888118044136 | 0888118044136 |
GMDN Terms
| Term | Definition |
|---|
| Craniofacial bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
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
- false
- 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 |
|---|
| 00888118145284 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-05-25 |
| 00888118145291 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-05-25 |
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| 07640187463408 | POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, Right | Bonebridge AG | HRS | 2026-05-22 |
| 07640187463415 | POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Left | Bonebridge AG | HRS | 2026-05-22 |
| 07640187463422 | POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Right | Bonebridge AG | HRS | 2026-05-22 |
| 07640187463439 | POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, Left | Bonebridge AG | HRS | 2026-05-22 |
| 07640187463446 | POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, Right | Bonebridge AG | HRS | 2026-05-22 |
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