| Primary Device ID | 09349967001035 |
| NIH Device Record Key | 20688f6e-8f65-4329-bc88-0166b04b5ea0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUMI ManipulatOR |
| Version Model Number | DUMI-350A |
| Company DUNS | 744346235 |
| Company Name | THE O R COMPANY PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349967001028 [Primary] |
| GS1 | 09349967001035 [Package] Contains: 09349967001028 Package: Outer Box [12 Units] In Commercial Distribution |
| GS1 | 09349967001042 [Package] Package: Shipper Box [10 Units] In Commercial Distribution |
| LKF | Cannula, Manipulator/Injector, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-26 |
| Device Publish Date | 2022-01-18 |