30mm x 14mm Paddle Shaver
- Primary DI
- B064XM22730141
- Brand
- 30mm x 14mm Paddle Shaver
- Company
- XENCO MEDICAL LLC
- Model
- XM-227-3014
- Device description
- 30mm x 14mm Paddle Shaver - Reusable
- Published
- 2016-04-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|
| B064XM22730141 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic chisel | A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 079282130
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- 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
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