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UNIFY RPGA Surgical Sutures

FDA UDI

Class II (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
UNIFY RPGA Surgical Sutures FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Undyed FDA UDI
Model / Reference
S-K418R13 FDA UDI
Description
UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Undyed FDA UDI

Identifiers

Primary DI / UDI-DI
00814639024340 FDA UDI
510(k) Number
K183004 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 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: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

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

Similar devices

Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.

Cleared under the same submission

K183004 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 61b46829-af8b-40bb-bc79-e54492885644 35 fields · synced Jun 1, 2026