AVO Cream
GUDID 00313811565904
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.
TRIGEN LABORATORIES, LLC
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial| Primary Device ID | 00313811565904 |
| NIH Device Record Key | 99e4312f-7626-4a18-94ee-3438854e57cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVO Cream |
| Version Model Number | 1381156590 |
| Company DUNS | 830479668 |
| Company Name | TRIGEN LABORATORIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com | |
| Phone | 7705094603 |
| molina@osmotica.com |
Device Dimensions
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
| Weight | 90 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00313811565904 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110762
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
On-Brand Devices [AVO Cream]
| 00313811565904 | AVO Cream™ Topical Emulsion is a water-based emulsion formulated for the dressing and manageme |
| 00313811565454 | AVO Cream™ Topical Emulsion is a water-based emulsion formulated for the dressing and manageme |
Trademark Results [AVO Cream]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVO CREAM 86024046 not registered Dead/Abandoned |
Trigen Laboratories, Inc. 2013-07-30 |
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