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HemCon ChitoFlex®, 1in x 3in

FDA UDI

Class U (US FDA UDI)

by Tricol Biomedical, INC.

Identity

Trade Name
HemCon ChitoFlex®, 1in x 3in FDA UDI
Generic Name
Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Device Name
The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied. FDA UDI
Model / Reference
1 FDA UDI
Description
The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied. FDA UDI

Identifiers

Catalog Number
1008 FDA UDI
Primary DI / UDI-DI
00870053001121 FDA UDI
510(k) Number
K080818 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

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

No

FDA UDI

Category: Chitosan haemostatic agent, professional, non-bioabsorbable

HemCon ChitoFlex®, 1in x 3in 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

K080818 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 10a44011-31c1-45fa-9f5e-c32260c5f2d3 37 fields · synced May 30, 2026