ColpotomizOR Tube System

GUDID 09349967003466

Uterine manipulator, single-use

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 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

HEW	Culdoscope (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true