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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, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18" FDA UDI
Model / Reference
S-F418T13 FDA UDI
Description
PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18" FDA UDI

Identifiers

Catalog Number
S-F418T13 FDA UDI
Primary DI / UDI-DI
00814639023671 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 937434d5-9ea1-4b62-8eff-79c70467334f 37 fields · synced May 29, 2026