Identity
- Trade Name
- GuardaCare®XR Surgical, 4in x 4in, 8ply FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch. FDA UDI
Identifiers
- Catalog Number
- 1032 FDA UDI
- Primary DI / UDI-DI
- 00870053000117 FDA UDI
- 510(k) Number
- K103641 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
GuardaCare®XR Surgical, 4in x 4in, 8ply 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.
- Celox Rapid Z-Fold Gauze — Medtrade Products , Ltd. · U
- QUIKCLOT — TELEFLEX INCORPORATED · U
- CELOX Gauze — Medtrade Products , Ltd. · U
- PosiSep X2 0.8" x 2.3" — Hemostasis, LLC · Class I
- CELOX Vascular — Medtrade Products , Ltd. · U
- Axiostat Patch — Advamedica, Inc. · U
- MaxioCel Chitosan Wound Dressing — Advamedica, Inc. · U
- Axiostat Gauze — Advamedica, Inc. · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Tricol Biomedical, INC.
Sources (1)
- FDA UDI be91851d-7907-41ee-917f-be0628150827 37 fields · synced Jun 8, 2026