Identity
- Trade Name
- Vitale FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Vitale Sacral Hydrocolloid Dressings, 6" x 7", 1/pouch, 10/box, 10 boxes/case FDA UDI
- Model / Reference
- 21290 FDA UDI
- Description
- Vitale Sacral Hydrocolloid Dressings, 6" x 7", 1/pouch, 10/box, 10 boxes/case FDA UDI
Identifiers
- Catalog Number
- 21290 FDA UDI
- Primary DI / UDI-DI
- 00856276008420 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
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, non-antimicrobial
Vitale by CellEra, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- CellEra, LLC
Sources (1)
- FDA UDI 0fc4bab7-da82-486d-bf49-cdf235d88c0d 35 fields · synced May 30, 2026