ColpotomizOR Tube System

GUDID 09349967003466

THE O R COMPANY PTY LTD

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• Primary Device ID: 09349967003466
• NIH Device Record Key: f48901a1-4b13-4247-9449-afad98d0eb37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColpotomizOR Tube System
• Version Model Number: CTS35-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	09349967003442 [Primary]
GS1	09349967003459 [Package]; Contains: 09349967003442; Package: Outer [5 Units]; In Commercial Distribution
GS1	09349967003466 [Package]; Contains: 09349967003459; 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 System]

• 09349967003497: CTS45-TV
• 09349967003466: CTS35-TV
• 29349967005006: CTS45-TV
• 29349967004993: CTS35-TV