| Primary Device ID | 00810198031577 |
| NIH Device Record Key | 8991799e-0f90-433f-94a5-06507056665f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerHeal Single Layer |
| Version Model Number | 4" x 4" |
| Catalog Number | PSK-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 | 00810198031577 [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 |
| 00810198031577 | PowerHeal Single Layer, 4"x 4" |
| 00810198031560 | PowerHeal Single Layer, 2" x 2" |