ColpotomizOR Tube C35-TV

GUDID 09349967001448

Colpotomy tube

Primary Device ID	09349967001448
NIH Device Record Key	614c3dd8-36f5-4d5a-b5e6-2fb919a92817
Commercial Distribution Status	In Commercial Distribution
Brand Name	ColpotomizOR Tube
Version Model Number	35mm
Catalog 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 Issuing Agency	Device ID
GS1	09349967001424 [Primary]
GS1	09349967001431 [Package] Contains: 09349967001424 Package: Outer Box [5 Units] In Commercial Distribution
GS1	09349967001448 [Package] Contains: 09349967001431 Package: Shipper box [3 Units] In Commercial Distribution

HEW	Culdoscope (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true

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