DemeGUT

FDA UDI

Class II (US FDA UDI)

by DemeTECH Corp

Identity

Trade Name: DemeGUT FDA UDI
Generic Name: Catgut suture, chromic FDA UDI
Device Name: Chromic Gut, Sterile, Absorbable Surgical Suture FDA UDI
Model / Reference: CC126011F4P FDA UDI
Description: Chromic Gut, Sterile, Absorbable Surgical Suture FDA UDI

Identifiers

Primary DI / UDI-DI: 10652927301219 FDA UDI
510(k) Number: K072930 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Catgut suture, chromic

The DemeGUT is a sterile, absorbable surgical suture used in general plastic surgery. It's an all-in-one device that combines the benefits of a single-strand (monofilament) thread with chromium salts to increase tensile strength and retard absorption. The DemeGUT is designed for temporary wound support until healing is sufficient, then it's absorbed by enzymatic degradation. This device is intended for use as a replacement for traditional sutures in general plastic surgery procedures.

Similar devices

Also classified as Catgut suture, chromic.

ETHICON — Ethicon Inc. · Class II
ETHICON — Ethicon Inc. · Class II
ACE Surgical Ch Gut 3-0 30" Hr26 — Surgical Specialties México, S. de R.L. de C.V. · Class II
ETHICON — Ethicon Inc. · Class II
ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
X-Gut™ Chromic Gut Suture — OSTEOGENICS BIOMEDICAL, INC. · Class II
ENDURE INDUSTRIES — ENDURE INDUSTRIES, INC. · Class II
ETHICON — Ethicon Inc. · Class II

Cleared under the same submission

K072930 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: DemeTECH Corp

Sources (1)

FDA UDI 7233d3c7-b134-4ace-9955-5be3c0410be4 36 fields · synced Jun 24, 2026