| Primary Device ID | 19349967005085 |
| NIH Device Record Key | c3674de7-d313-4889-9068-bb15b6dbfdc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uterine ElevatOR PRO with Long Handle™ |
| Version Model Number | UE-LHPRO-37NT |
| Catalog Number | UE-LHPRO-37NT |
| 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 |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Outer Diameter | 37 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349967005088 [Primary] |
| GS1 | 19349967005085 [Package] Contains: 09349967005088 Package: Outer Box [8 Units] In Commercial Distribution |
| GS1 | 29349967005082 [Package] Package: Shipper Box [6 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 | 2023-06-05 |
| Device Publish Date | 2023-05-26 |
| 19349967005092 | UE-LHPRO-40NT |
| 19349967005085 | UE-LHPRO-37NT |
| 19349967005078 | UE-LHPRO-35NT |
| 19349967005061 | UE-LHPRO-32NT |