| Primary Device ID | 00894318002258 |
| NIH Device Record Key | 700e6f85-2ef7-4dca-88d8-1ea08a603bbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Energel Wound Hydrogel |
| Version Model Number | 7.5g / 0.26oz |
| Catalog Number | NRG-L075-10 |
| Company DUNS | 080126901 |
| Company Name | Vomaris Wound Care, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894318002258 [Primary] |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-09 |
| Device Publish Date | 2023-08-01 |
| 00894318002258 | Energel Wound Hydrogel 7.5g / 0.26oz, Box of 10 |
| 00894318002241 | Energel Wound Hydrogel 7.5g / 0.26oz |