MaxBraid Suture BroadBand Tape (Basic)
- Primary DI
- 00840277401397
- Brand
- MaxBraid Suture BroadBand Tape (Basic)
- Company
- RIVERPOINT MEDICAL, LLC
- Model
- 110046602
- Device description
- Subscapularis Repair Suture Kit-Basic (Suture Kit - KIT703 is convenience kit containing HS Fiber sutures (K190817; K153307) and Drill Bit (HTW, 510k exempt)).
- Published
- 2022-07-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840277401397 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840277401397 | 00840277401397 | 840277401397 | 0840277401397 |
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. |
Regulatory Flags
- DUNS number
- 964053560
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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
Other Devices From This Company