Open Soft Tissue Repair Suture Kit-Small
- Primary DI
- 00840277401403
- Brand
- Open Soft Tissue Repair Suture Kit-Small
- Company
- RIVERPOINT MEDICAL, LLC
- Model
- 3910-900-145
- Device description
- Suture Kit - KIT201 is convenience kit containing HS Fiber sutures (K190817; K153307) and Orthopedic Surgical Needle (HWQ, 510k exempt).
- Published
- 2022-11-04
- 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 |
|---|
| 00840277401403 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840277401403 | 00840277401403 | 840277401403 | 0840277401403 |
GMDN Terms
| Term | Definition |
|---|
| Polyolefin suture, multifilament | A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) 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
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