Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-32NT

GUDID 19349967005016

THE O R COMPANY PTY LTD

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• Primary Device ID: 19349967005016
• NIH Device Record Key: 52e9123d-4615-4d81-9041-0f43b6fe032e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uterine ElevatOR PRO with OccludOR Balloon™
• Version Model Number: UE-OBPRO-32NT
• Catalog Number: UE-OBPRO-32NT
• 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 Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349967005019 [Primary]
GS1	19349967005016 [Package]; Contains: 09349967005019; Package: Outer box [8 Units]; In Commercial Distribution
GS1	29349967005013 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-05
• Device Publish Date: 2023-05-26

On-Brand Devices [Uterine ElevatOR PRO with OccludOR Balloon™]

• 19349967005016: UE-OBPRO-32NT
• 19349967004989: UE-OBPRO-40NT
• 19349967004972: UE-OBPRO-37NT
• 19349967004965: UE-OBPRO-35NT