| Primary Device ID | B086291312 |
| NIH Device Record Key | 4cbd4f60-2a3b-4fc2-80ee-274a43fa5bea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protect U Guard Silicone Foam Sterile Dressing |
| Version Model Number | P19131 |
| Company DUNS | 080070945 |
| Company Name | PROTECT U GUARD, LLC |
| Device Count | 10 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Width | 10 Centimeter |
| Length | 10 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B086091310 [Unit of Use] |
| HIBCC | B086191311 [Primary] |
| HIBCC | B086291312 [Package] Contains: B086191311 Package: CARTON [540 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-31 |
| Device Publish Date | 2020-08-21 |
| B086291322 | Protect U Guard Silicone Foam Sterile Dressing 15x15cm |
| B086291312 | Protect U Guard Silicone Foam Sterile Dressing 10x10cm |