| Primary Device ID | 00810198031539 |
| NIH Device Record Key | 71bd4322-579e-47a1-bf60-74911a8a359a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerHeal 3-layer clear adhesive |
| Version Model Number | 4"x4" |
| Catalog Number | PFK-4040 |
| Company DUNS | 080126901 |
| Company Name | Vomaris Wound Care, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810198031539 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
| 00810198031553 - PowerHeal Energel | 2024-03-11 Energel - Single Sterile Sachet 7.5g / 0.26oz |
| 00810198031447 - PowerHeal Kit | 2024-03-08 PowerHeal Kit, 4"x4" 3-layer clear adhesive & Energel |
| 00810198031454 - PowerHeal Kit | 2024-03-08 PowerHeal Kit, 6"x6" 3-layer & Energel |
| 00810198031461 - PowerHeal Kit | 2024-03-08 PowerHeal Kit, 2.3"x 3.5" 3-layer clear adhesive & Energel |
| 00810198031478 - PowerHeal Kit | 2024-03-08 PowerHeal Combo Kit, 4"x4", 6"x6", 2.3"x3.5" (3-layer clear adhesive) & Energel |
| 00810198031485 - PowerHeal Kit | 2024-03-08 PowerHeal Kit, 2"x2" Single Layer & Energel |
| 00810198031492 - PowerHeal Kit | 2024-03-08 PowerHeal, 4"x4" Single Layer, & Energel |
| 00810198031508 - PowerHeal Kit | 2024-03-08 PowerHeal Kit, 2"x2" Single Layer, Energel & Tegaderm |