Identity
- Trade Name
- UNIFY PTFE Surgical Sutures FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
- Device Name
- PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18" FDA UDI
- Model / Reference
- S-F418R13 FDA UDI
- Description
- PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18" FDA UDI
Identifiers
- Catalog Number
- S-F418R13 FDA UDI
- Primary DI / UDI-DI
- 00814639023664 FDA UDI
- 510(k) Number
- K170842 FDA UDI
- FDA Product Code
- NBY FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5035 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
Yes
FDA UDI
Category: Polyolefin/fluoropolymer suture, multifilament
UNIFY PTFE Surgical Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyolefin/fluoropolymer suture, multifilament.
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- FORCE FIBER — TELEFLEX INCORPORATED · Class II
- Arthrex® — Arthrex, Inc. · Class II
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Cleared under the same submission
K170842 also covers:
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PTFE Surgical Sutures — APPLIED DENTAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Dental, Inc.
Sources (1)
- FDA UDI 91f24008-0710-47e9-b5d8-452cc98139f7 36 fields · synced May 30, 2026