Identity
- Trade Name
- CALICO FDA UDI
- Generic Name
- Cavity-wound management dressing, antimicrobial FDA UDI
- Device Name
- AG Silver Silicone Foam Dressing, Bordered, 4" x 4" FDA UDI
- Model / Reference
- FD008 FDA UDI
- Description
- AG Silver Silicone Foam Dressing, Bordered, 4" x 4" FDA UDI
Identifiers
- Catalog Number
- FD008 FDA UDI
- Primary DI / UDI-DI
- 00850044458530 FDA UDI
- 510(k) Number
- K191819 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Cavity-wound management dressing, antimicrobial 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cavity-wound management dressing, antimicrobial
Calico by Calico Medical Group LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cavity-wound management dressing, antimicrobial.
- SiliGentle AG Silver Silicone Foam Dressing — Dynarex Corp. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DynaGinate AG Silver Calcium Alginate Rope Dressing — Dynarex Corp. · U
- ColActive Plus Powder Ag Wound Filler — HARTMANN USA INC. · U
- SiliGentle AG Silver Silicone Foam Dressing — Dynarex Corp. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- ColActive Plus Powder Wound Filler — HARTMANN USA INC. · U
- DynaFoam AG Silver Foam Dressing, Bordered — Dynarex Corp. · U
Cleared under the same submission
K191819 also covers:
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
- Calico Medical Group LLC
Sources (1)
- FDA UDI 2f66dadb-ac5f-49dd-a542-c3f69fe72d80 35 fields · synced May 30, 2026