| Primary Device ID | 00850037747269 |
| NIH Device Record Key | 66f627fc-df0c-435d-87f5-34a69f2630eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeSource Shoe Covers |
| Version Model Number | SC3001 |
| Company DUNS | 118070602 |
| Company Name | Safesource Direct, L.L.C. |
| Device Count | 100 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850037747269 [Primary] |
| GS1 | 00850037747627 [Unit of Use] |
| GS1 | 10850037747266 [Package] Package: Case [4 Units] In Commercial Distribution |
| FXP | Cover, Shoe, Operating-Room |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-24 |
| Device Publish Date | 2023-05-16 |
| 10850037747464 - Extra Large Blue Shoe Cover | 2024-10-18 Extra Large Blue Shoe Cover with Tread. |
| 10850037747471 - Universal Shoe Cover Super Tread | 2024-10-18 Universal Size Blue Shoe Cover with Tread |
| 10850037747488 - Extra Large Extra Traction Shoe Cover | 2024-10-18 Extra Large Blue Shoe cover with Extra Traction. |
| 10850037747228 - Bouffant Cap 21" White | 2024-10-09 White Bouffant Cap 21" outside diameter. |
| 10850037747235 - Bouffant Cap 21" Blue | 2024-10-09 Blue Bouffant Cap 21" outside diameter. |
| 10850037747242 - Bouffant Cap 24" White | 2024-10-09 White Bouffant Cap 21" outside diameter. |
| 10850037747259 - Bouffant Cap 24" Blue | 2024-10-09 Blue Bouffant Cap 24" outer diameter. |
| 00850037747382 - Plant Based Procedural Mask | 2024-04-15 Plant Based Procedural Mask ASTM Level 3 with ear loops |