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UNIFY PTFE Surgical Sutures

FDA UDI

Class II (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
UNIFY PTFE Surgical Sutures FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30" FDA UDI
Model / Reference
XXL-F330K50 FDA UDI
Description
PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30" FDA UDI

Identifiers

Primary DI / UDI-DI
00814639024852 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
Not 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

UNIFY PTFE Surgical Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K170842 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Dental, Inc.

Sources (1)

  • FDA UDI 2e37feb6-ec42-4f71-8ae7-92ed8e7aa14b 36 fields · synced Jun 6, 2026