Identity
- Trade Name
- Vitale FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Vitale Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case FDA UDI
- Model / Reference
- 20522 FDA UDI
- Description
- Vitale Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case FDA UDI
Identifiers
- Catalog Number
- 20522 FDA UDI
- Primary DI / UDI-DI
- 00856276008758 FDA UDI
- 510(k) Number
- K143335 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-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
No
FDA UDI
Over-the-Counter
Yes
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: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Vitale by CellEra, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
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- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc · U
Cleared under the same submission
K143335 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
- CellEra, LLC
Sources (1)
- FDA UDI a9dadbf4-e74b-41dd-be4e-3cc9605cb69c 36 fields · synced Jun 7, 2026