ColpotomizOR Tube System CTS35-TV

GUDID 09349967000328

Colpotomy tube

Primary Device ID	09349967000328
NIH Device Record Key	455574f0-540a-4d3a-a947-920efa6a64b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	ColpotomizOR Tube System
Version Model Number	35mm
Catalog Number	CTS35-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 Issuing Agency	Device ID
GS1	09349967000304 [Primary]
GS1	09349967000311 [Package] Contains: 09349967000304 Package: Outer Box [5 Units] In Commercial Distribution
GS1	09349967000328 [Package] Contains: 09349967000311 Package: Shipper Carton [3 Units] In Commercial Distribution

HEW	Culdoscope (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true

09349967000335	45mm diameter trans-vaginal tube and uterine manipulator
09349967000328	35mm diameter trans-vaginal tube and uterine manipulator