OsseoFit™ Subscapularis Kit (Suture Anchor)
- Primary DI
- 00840277404992
- Brand
- OsseoFit™ Subscapularis Kit (Suture Anchor)
- Company
- RIVERPOINT MEDICAL, LLC
- Model
- 120002050
- Device description
- Subscapularis Repair Suture Kit-Suture Anchor
- Published
- 2024-12-31
- 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 |
|---|
| 00840277404992 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840277404992 | 00840277404992 | 840277404992 | 0840277404992 |
GMDN Terms
| Term | Definition |
|---|
| Polyolefin/fluoropolymer suture, multifilament | A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. 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