Medtronic Reusable Instruments
- Primary DI
- 00613994808219
- Brand
- Medtronic Reusable Instruments
- Company
- MEDTRONIC SOFAMOR DANEK, INC.
- Model
- PFF0001
- Device description
- INSTRUMENT KIT PFF0001 FACET FIXATION
- Published
- 2023-08-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HTW | Bit, Drill | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00613994808219 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00613994808219 | 00613994808219 | 613994808219 | 0613994808219 |
GMDN Terms
| Term | Definition |
|---|
| Neurosurgical curette, single-use | A hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a single-use device. |
Regulatory Flags
- DUNS number
- 830350380
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
- false
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