ColpotomizOR Tube C35-TV

GUDID 09349967000267

35mm diameter trans-vaginal tube

SURGI SUPPLIES INTERNATIONAL PTY. LTD.

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• Primary Device ID: 09349967000267
• NIH Device Record Key: fcd412e6-c6fc-4d56-ba86-362ef8a4698f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColpotomizOR Tube
• Version Model Number: 35mm
• Catalog Number: C35-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: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349967000243 [Primary]
GS1	09349967000250 [Package]; Contains: 09349967000243; Package: Outer box [5 Units]; In Commercial Distribution
GS1	09349967000267 [Package]; Contains: 09349967000250; Package: Shipper Carton [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-09-22

On-Brand Devices [ColpotomizOR Tube]

• 09349967000298: 45mm diameter trans-vaginal tube
• 09349967000267: 35mm diameter trans-vaginal tube