Identity
- Trade Name
- Hi-Fi Ribbon FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
- Device Name
- Suture FDA UDI
- Model / Reference
- HR713B FDA UDI
- Description
- Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812444028379 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyolefin/fluoropolymer suture, multifilament
Hi-Fi Ribbon by Riverpoint Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, multifilament.
- Arthrex® — Arthrex, Inc. · Class II
- FORCE FIBER — TELEFLEX INCORPORATED · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HI-FI — TELEFLEX INCORPORATED · Class II
- FORCE FIBER — TELEFLEX INCORPORATED · Class II
- FORCE FIBER — TELEFLEX INCORPORATED · Class II
- Arthrex® — Arthrex, Inc. · Class II
- TELEFLEX — TELEFLEX INCORPORATED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Riverpoint Medical Llc
Sources (1)
- FDA UDI 33756c16-0a0b-4fef-8050-84f783abacbb 33 fields · synced May 31, 2026