ColpotomizOR Tube System

GUDID 29349967005006

Uterine manipulator, single-use

Primary Device ID	29349967005006
NIH Device Record Key	69c5b628-c13c-4e94-9341-16b7d43f91c4
Commercial Distribution Status	In Commercial Distribution
Brand Name	ColpotomizOR Tube System
Version Model Number	CTS45-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	19349967005009 [Primary]
GS1	29349967005006 [Package] Contains: 19349967005009 Package: outer [5 Units] In Commercial Distribution
GS1	39349967005003 [Package] Package: Shipper [3 Units] In Commercial Distribution

HEW	Culdoscope (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true