| Primary Device ID | 19349967004965 |
| NIH Device Record Key | 12f272bc-4cb8-4cab-b21c-3014a4fc7d65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uterine ElevatOR PRO with OccludOR Balloon™ |
| Version Model Number | UE-OBPRO-35NT |
| Catalog Number | UE-OBPRO-35NT |
| 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 | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349967004968 [Primary] |
| GS1 | 19349967004965 [Package] Contains: 09349967004968 Package: Outer box [8 Units] In Commercial Distribution |
| GS1 | 29349967004962 [Package] Contains: 09349967004968 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 |
| 19349967005016 | UE-OBPRO-32NT |
| 19349967004989 | UE-OBPRO-40NT |
| 19349967004972 | UE-OBPRO-37NT |
| 19349967004965 | UE-OBPRO-35NT |