← Back to catalogue

Premium UNIFY Nylon Sutures

FDA UDI

Class II (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
Premium UNIFY Nylon Sutures FDA UDI
Generic Name
Nylon suture, non-bioabsorbable, monofilament FDA UDI
Device Name
Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18", Undyed FDA UDI
Model / Reference
PMNU-518R19 FDA UDI
Description
Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18", Undyed FDA UDI

Identifiers

Primary DI / UDI-DI
00814639023558 FDA UDI
FDA Product Code
GAR FDA UDI
GMDN Term
Nylon suture, non-bioabsorbable, monofilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5020 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: Nylon suture, non-bioabsorbable, monofilament

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

Similar devices

Also classified as Nylon suture, non-bioabsorbable, monofilament.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Applied Dental, Inc.

Sources (1)

  • FDA UDI 74d80ae6-4c2c-4a5e-a505-3057fbcff4f7 34 fields · synced Jun 7, 2026