ColpotomizOR Tube

GUDID 09349967002599

THE O R COMPANY PTY LTD

Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube Colpotomy tube

• Primary Device ID: 09349967002599
• NIH Device Record Key: c4d71653-467d-4ca9-970f-29b8d24c4a0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColpotomizOR Tube
• Version Model Number: C35-TV
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349967002575 [Primary]
GS1	09349967002582 [Package]; Contains: 09349967002575; Package: Outer [5 Units]; In Commercial Distribution
GS1	09349967002599 [Package]; Contains: 09349967002582; Package: Shipper [3 Units]; In Commercial Distribution

FDA Product Code

• HEW: Culdoscope (And Accessories)

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: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [ColpotomizOR Tube]

• 09349967002629: C45-TV
• 09349967002599: C35-TV
• 09349967001479: 45mm diameter trans-vaginal tube, 3 way valve, Silicone tie
• 09349967001448: 35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie