| Primary Device ID | 10190769003552 |
| NIH Device Record Key | ef0eb1a7-b6c2-483f-9966-2edcdfc2ecc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vashe Sterile Sleeve |
| Version Model Number | 00355 |
| Catalog Number | 00355 |
| Company DUNS | 052758618 |
| Company Name | URGO MEDICAL NORTH AMERICA, LLC |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 10190769004054 - Vashe Wound Solution OTC | 2021-12-15 Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in |
| 10190769085961 - Resta Silver Gel Bellows Bottle | 2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera |
| 00190769085971 - Resta Silver Gel Tube | 2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera |
| 10851383003174 - Vashe Wound Solution 475 ml (16 fl oz) Instillation Container | 2020-04-09 Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption |
| 10851383003228 - Vashe Wound Solution 1 L (34 fl oz) Flip Top Container | 2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption |
| 10851383003235 - Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container | 2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption |
| 00190769532451 - URGOK2 Lite (Short) Kit | 2020-02-20 URGOK2 Lite is a two layer Compression System which includes KTECH Lite: a white, short-stretch bandage; providing compression, |
| 10190769532465 - URGOK2 Lite (Long) Kit | 2020-02-20 URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and a |