| Primary Device ID | 00860003700860 |
| NIH Device Record Key | 06e21eea-1382-402b-b897-b6f142cc0974 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hays Inc |
| Version Model Number | HS2100SS |
| Catalog Number | HS2100SS |
| Company DUNS | 079906040 |
| Company Name | HAYS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003700853 [Primary] |
| GS1 | 00860003700860 [Package] Contains: 00860003700853 Package: INNER CASE [100 Units] In Commercial Distribution |
| GS1 | 00860003700877 [Package] Contains: 00860003700853 Package: CASE [1 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-12 |
| Device Publish Date | 2021-02-04 |
| 00860003700808 | Hays Innovations Sterile Ultrasound Probe Cover Kit |
| 00860003700860 | Hays Innovations Sterile Short US Probe Cover Kit |
| 00860003700853 | Hays Innovations Sterile Short US Probe Cover Kit |