Pro-X1
- Primary DI
- 05397283000298
- Brand
- Pro-X1
- Company
- X-BOLT ORTHOPEDICS INC.
- Model
- XBT040305
- Device description
- Ø4.0mm x 305mm Drill Bit, quick connect (Metro Jig™)
- Published
- 2024-08-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HSB | Rod, Fixation, Intramedullary And Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05397283000298 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05397283000298 | 05397283000298 | 5397283000298 |
GMDN Terms
| Term | Definition |
|---|
| Fluted surgical drill bit, single-use | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 305 | Millimeter |
Regulatory Flags
- DUNS number
- 119116284
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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