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 |