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Pga Resorba

FDA UDI

Class II (US FDA UDI)

by Resorba Medical GmbH

Identity

Trade Name
PGA RESORBA FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Model / Reference
PGA RESORBA FDA UDI

Identifiers

Primary DI / UDI-DI
E203OD034009 FDA UDI
510(k) Number
K143584 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
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

Yes

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

The PGA Resorba is a high-quality, clinically-tested medical device used for suturing soft-tissue wounds or incisions. This polyester suture is designed to provide extended temporary wound support until the wound heals sufficiently, then it is absorbed by hydrolysis.

Cleared under the same submission

K143584 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resorba Medical GmbH

Sources (1)

  • FDA UDI 558bf83a-b695-4a3d-a913-3eccb4159d6c 34 fields · synced Oct 6, 2026