Identity
- Trade Name
- Parcus Braid FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
- Device Name
- Sterile Infinity Loop Parcus Braid 2 w/ Needle FDA UDI
- Model / Reference
- 20053 FDA UDI
- Description
- Sterile Infinity Loop Parcus Braid 2 w/ Needle FDA UDI
Identifiers
- Catalog Number
- 20053 FDA UDI
- Primary DI / UDI-DI
- M685200531 FDA UDI
- 510(k) Number
- K100006 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
Yes
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
MR Safe FDA UDI
Category: Polyolefin/fluoropolymer suture, multifilament
Parcus Braid by Parcus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, multifilament.
- XBraid TT — RIVERPOINT MEDICAL LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HS Fiber — RIVERPOINT MEDICAL LLC · 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
- CuffCable — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
K100006 also covers:
- HI-FI — Conmed Corporation
- Hi-Fi — Conmed Corporation
- Hi-Fi — Conmed Corporation
- SUTURE LOOP HI-FI — Conmed Corporation
- SUTURE LOOP HI-FI — Conmed Corporation
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
- Parcus Braid — PARCUS MEDICAL LLC
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
- Parcus Medical Llc
Sources (1)
- FDA UDI df5e65d6-c694-4586-af36-d58166d6c429 36 fields · synced May 30, 2026