Identity
- Trade Name
- AVO Cream FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- AVO Cream™ Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream™ Topical Emulsion provides an optimum moist environment for the healing process and provides temporary wound protection from harmful germs and other external contamination. FDA UDI
- Model / Reference
- 1381156545 FDA UDI
- Description
- AVO Cream™ Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream™ Topical Emulsion provides an optimum moist environment for the healing process and provides temporary wound protection from harmful germs and other external contamination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00313811565454 FDA UDI
- 510(k) Number
- K110762 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Weight — 45 Gram FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
AVO Cream by Trigen Laboratories, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110762 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
- Trigen Laboratories, Inc.
Sources (1)
- FDA UDI 367d2c62-7dc5-440c-ac51-7ce1dac381c4 37 fields · synced May 30, 2026