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HemCon ChitoGauze XR2 Pro, 3in x 4yd

FDA UDI

Class U (US FDA UDI)

by Tricol Biomedical, INC.

Identity

Trade Name
HemCon ChitoGauze XR2 Pro, 3in x 4yd FDA UDI
Generic Name
Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Device Name
HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds. FDA UDI
Model / Reference
1 FDA UDI
Description
HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds. FDA UDI

Identifiers

Catalog Number
1101 FDA UDI
Primary DI / UDI-DI
00870053000315 FDA UDI
510(k) Number
K102546 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 ChitoGauze XR2 Pro, 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

K102546 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 29d5037c-b8b5-4424-b9b2-678e0508769a 36 fields · synced May 29, 2026