ColpotomizOR Tube

GUDID 09349967002599

THE O R COMPANY PTY LTD

Colpotomy tube
Primary Device ID09349967002599
NIH Device Record Keyc4d71653-467d-4ca9-970f-29b8d24c4a0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpotomizOR Tube
Version Model NumberC35-TV
Company DUNS744346235
Company NameTHE O R COMPANY PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109349967002575 [Primary]
GS109349967002582 [Package]
Contains: 09349967002575
Package: Outer [5 Units]
In Commercial Distribution
GS109349967002599 [Package]
Contains: 09349967002582
Package: Shipper [3 Units]
In Commercial Distribution

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [ColpotomizOR Tube]

09349967002629C45-TV
09349967002599C35-TV
0934996700147945mm diameter trans-vaginal tube, 3 way valve, Silicone tie
0934996700144835mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie

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