34mm x 28mm x 15mm x 20° ALIF Rasp
- Primary DI
- B064XM33420151
- Brand
- 34mm x 28mm x 15mm x 20° ALIF Rasp
- Company
- XENCO MEDICAL LLC
- Model
- XM-334-2015
- Published
- 2015-10-29
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B064XM33420151 | 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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|---|
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| B064XM11510001 | Pedicle Screw Instruments Kit | XM-115-1000 | | 2022-08-11 |
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| B064XM12723451 | 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights | XM-127-2345 | | 2015-10-28 |
| B064XM12789011 | 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights | XM-127-8901 | | 2015-10-28 |
| B064XM12823451 | 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights | XM-128-2345 | | 2016-07-06 |
| B064XM12889011 | 28mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm Heights | XM-128-8901 | | 2015-10-28 |
| B064XM21565501 | Ø6.5mm x 50mm Pedicle Screw with Set Screw Package | XM-215-6550 | | 2015-10-27 |
| B064XM21565551 | Ø6.5mm x 55mm Pedicle Screw with Set Screw Package | XM-215-6555 | | 2015-10-27 |
| B064XM21575251 | Ø7.5mm x 25mm Pedicle Screw with Set Screw Package | XM-215-7525 | | 2015-10-27 |
| B064XM21575271 | Ø7.5mm x 27mm Pedicle Screw with Set Screw Package | XM-215-7527 | | 2015-11-03 |
| B064XM21575301 | Ø7.5mm x 30mm Pedicle Screw with Set Screw Package | XM-215-7530 | | 2015-11-03 |
| B064XM21575321 | Ø7.5mm x 32mm Pedicle Screw with Set Screw Package | XM-215-7532 | | 2015-11-03 |