ManipulatOR UM-TV

GUDID 09349967000021

Uterine Manipulator

SURGI SUPPLIES INTERNATIONAL 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

• Primary Device ID: 09349967000021
• NIH Device Record Key: 1845dc43-5913-4416-831e-5cfe06f611ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManipulatOR
• Version Model Number: UM-TV
• Catalog Number: UM-TV
• Company DUNS: 753476779
• Company Name: SURGI SUPPLIES INTERNATIONAL 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	09349967000007 [Primary]
GS1	09349967000014 [Package]; Contains: 09349967000007; Package: Outer Box [5 Units]; In Commercial Distribution
GS1	09349967000021 [Package]; Contains: 09349967000014; Package: Shipper Box [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-11-09

Devices Manufactured by SURGI SUPPLIES INTERNATIONAL PTY. LTD.

• 09349967000021 - ManipulatOR: 2023-04-04Uterine Manipulator
• 09349967000021 - ManipulatOR: 2023-04-04 Uterine Manipulator
• 09349967000267 - ColpotomizOR Tube: 2023-04-04 35mm diameter trans-vaginal tube
• 09349967000298 - ColpotomizOR Tube: 2023-04-04 45mm diameter trans-vaginal tube
• 09349967000328 - ColpotomizOR Tube System: 2023-04-04 35mm diameter trans-vaginal tube and uterine manipulator
• 09349967000335 - ColpotomizOR Tube System: 2023-04-04 45mm diameter trans-vaginal tube and uterine manipulator