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ChitoGauze®, OTC, 3in x 48in

FDA UDI

Class U (US FDA UDI)

by Tricol Biomedical, INC.

Identity

Trade Name
ChitoGauze®, OTC, 3in x 48in FDA UDI
Generic Name
Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Device Name
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds. FDA UDI
Model / Reference
1 FDA UDI
Description
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds. FDA UDI

Identifiers

Catalog Number
1030 FDA UDI
Primary DI / UDI-DI
00870053000292 FDA UDI
510(k) Number
K092357 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Category: Chitosan haemostatic agent, professional, non-bioabsorbable

ChitoGauze®, OTC, 3in x 48in by Tricol Biomedical, INC. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.

Cleared under the same submission

K092357 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tricol Biomedical, INC.

Sources (1)

  • FDA UDI 41fd73ba-33de-42cf-af26-c71fe37b96fb 36 fields · synced May 30, 2026