DUMI ManipulatOR

GUDID 09349967001035

Diagnostic Uterine Manipulator Injector

THE O R COMPANY PTY LTD

Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use

• 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 Identifiers

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

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212505

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: 2022-01-26
• Device Publish Date: 2022-01-18

Devices Manufactured by THE O R COMPANY PTY LTD

• 19349967004965 - Uterine ElevatOR PRO with OccludOR Balloon™: 2023-06-05
• 19349967004972 - Uterine ElevatOR PRO with OccludOR Balloon™: 2023-06-05
• 19349967004989 - Uterine ElevatOR PRO with OccludOR Balloon™: 2023-06-05
• 19349967005016 - Uterine ElevatOR PRO with OccludOR Balloon™: 2023-06-05
• 19349967005061 - Uterine ElevatOR PRO with Long Handle™: 2023-06-05
• 19349967005078 - Uterine ElevatOR PRO with Long Handle™: 2023-06-05
• 19349967005085 - Uterine ElevatOR PRO with Long Handle™: 2023-06-05
• 19349967005092 - Uterine ElevatOR PRO with Long Handle™: 2023-06-05