| Primary Device ID | 00616784213422 |
| NIH Device Record Key | b586f246-8c4a-433a-9688-67285156e06a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoe Cover |
| Version Model Number | 2134 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 300 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784213422 [Unit of Use] |
| GS1 | 00616784213439 [Primary] |
| 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 | 2021-06-29 |
| Device Publish Date | 2021-06-21 |
| 00616784213422 | Shoe Cover, Non-Conductive and Non-Skid, XL |
| 00616784213224 | Shoe Cover- Universal Size, Non-Conductive, Non-Skid, 150 Pairs |
| 00616784213125 | Shoe Cover- Universal Size, Non-Conductive, 150 Pairs |
| 00810180843140 | Shoe Cover, Non-Conductive and Non-Skid, XL |
| 00810180843133 | Shoe Cover- Universal Size, Non-Conductive, Non-Skid, 150 Pairs |
| 00810180843126 | Shoe Cover- Universal Size, Non-Conductive, 150 Pairs |