ColpotomizOR Tube System CTS45-TV

GUDID 09349967000335

45mm diameter trans-vaginal tube and 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: 09349967000335
• NIH Device Record Key: 41f57e3b-2200-4133-bc33-edbedb6dfce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColpotomizOR Tube System
• Version Model Number: 45mm
• Catalog Number: CTS45-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 Dimensions

• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349967000335 [Primary]
GS1	09349967000342 [Package]; Package: Outer Box [5 Units]; In Commercial Distribution
GS1	09349967000359 [Package]; Contains: 09349967000342; Package: Shipper Carton [3 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: 2016-09-22

On-Brand Devices [ColpotomizOR Tube System]

• 09349967000335: 45mm diameter trans-vaginal tube and uterine manipulator
• 09349967000328: 35mm diameter trans-vaginal tube and uterine manipulator