← Back to catalogue

ChitoGauzeXL, OTC, 3in x 4yd

FDA UDI

Class U (US FDA UDI)

by Tricol Biomedical, INC.

Identity

Trade Name
ChitoGauzeXL, OTC, 3in x 4yd 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
1025 FDA UDI
Primary DI / UDI-DI
00870053000308 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

ChitoGauzeXL, OTC, 3in x 4yd 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tricol Biomedical, INC.

Sources (1)

  • FDA UDI fdc251c2-5f7c-43d8-a8c8-c8ca5501dc76 36 fields · synced May 30, 2026