34mm x 28mm x 8° ALIF Rasp Kit 11, 13, 15, 17mm He
- Primary DI
- B064XM34813571
- Brand
- 34mm x 28mm x 8° ALIF Rasp Kit 11, 13, 15, 17mm He
- Company
- XENCO MEDICAL LLC
- Model
- XM-348-1357
- Device description
- 34mm x 28mm x 8° ALIF Rasps: 11, 13, 15, 17mm Heights
- Published
- 2015-10-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B064XM34813571 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone file/rasp, manual | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 079282130
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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