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Premium UNIFY Chromic Sutures

FDA UDI

Class II (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
Premium UNIFY Chromic Sutures FDA UDI
Generic Name
Catgut suture, chromic FDA UDI
Device Name
Premium UNIFY Chromic Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" FDA UDI
Model / Reference
PSC-418R13 FDA UDI
Description
Premium UNIFY Chromic Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" FDA UDI

Identifiers

Primary DI / UDI-DI
00814639021370 FDA UDI
FDA Product Code
GAL FDA UDI
GMDN Term
Catgut suture, chromic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4830 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: Catgut suture, chromic

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

Similar devices

Also classified as Catgut suture, chromic.

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 e3a1ca9f-016e-4e1c-8538-81d4ab168981 34 fields · synced May 30, 2026