BioScrew HyperFlex
- Primary DI
- 20845854041694
- Brand
- BioScrew HyperFlex
- Company
- Conmed Corporation
- Model
- C8006D
- Catalog number
- C8006D
- Device description
- BioScrew HyperFlex Guidewire, Nitinol, 14in, Sterile
- Published
- 2021-10-12
- 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 Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20845854041694 | Package | GS1 | 1 | In Commercial Distribution |
| 10845854041697 | Primary | GS1 | 0 | |
| 00845854041690 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 20845854041694 | 20845854041694 | | |
| 10845854041697 | 10845854041697 | | |
| 00845854041690 | 00845854041690 | 845854041690 | 0845854041690 |
GMDN Terms
| Term | Definition |
|---|
| Surgical drill guide, single-use | A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | KEEP DRY |
Regulatory Flags
- DUNS number
- 071595540
- Device count
- 5
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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