| Primary Device ID | 00850003355955 |
| NIH Device Record Key | e0c6be08-fed4-4a27-8d99-184624a34242 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORI |
| Version Model Number | OH-3 |
| Catalog Number | OH-3 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003355948 [Primary] |
| GS1 | 00850003355955 [Package] Contains: 00850003355948 Package: Case [25 Units] In Commercial Distribution |
| LYU | Accessory, Surgical Apparel |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2019-12-02 |
| 00850003355672 | ORI-Specialty Drape Line Direct Anterior Hip |
| 00850003355955 | Face Shield, Attached with Full Head Covering |
| 00850003355931 | Shield Guards-Removable Peel Away |
| 10850003355914 | SoloFit AAMI IV SMS Gown L, Extra Long |
| 00850015378270 | SterileBack Toga XL-EL |
| 00850015378621 | Solofit AAMI III SMS Gown Poly Reinforced XXX-Large |