Identity
- Trade Name
- CalciCare FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- Calcium Alginate Silver Dressing FDA UDI
- Model / Reference
- 529969R FDA UDI
- Description
- Calcium Alginate Silver Dressing FDA UDI
Identifiers
- Catalog Number
- 529969R FDA UDI
- Primary DI / UDI-DI
- 10610075029591 FDA UDI
- 510(k) Number
- K090453 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, 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
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
Dimensions & Sizes
- Size
- Length — 46 Centimeter FDA UDIWidth — 2.5 Centimeter FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
CalciCare by Hollister Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
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Cleared under the same submission
K090453 also covers:
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN Alginate Ag — ADVANCED MEDICAL SOLUTIONS LIMITED
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
- Hollister Incorporated
Sources (1)
- FDA UDI da4707b5-8a8c-4ab7-b9d2-5f88a2a258fb 38 fields · synced Jun 9, 2026