ColpotomizOR Tube C35-TV

GUDID 09349967000267

35mm diameter trans-vaginal tube

SURGI SUPPLIES INTERNATIONAL PTY. LTD.

Colpotomy tube
Primary Device ID09349967000267
NIH Device Record Keyfcd412e6-c6fc-4d56-ba86-362ef8a4698f
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpotomizOR Tube
Version Model Number35mm
Catalog NumberC35-TV
Company DUNS753476779
Company NameSURGI SUPPLIES INTERNATIONAL 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 Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109349967000243 [Primary]
GS109349967000250 [Package]
Contains: 09349967000243
Package: Outer box [5 Units]
In Commercial Distribution
GS109349967000267 [Package]
Contains: 09349967000250
Package: Shipper Carton [3 Units]
In Commercial Distribution

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-04-04
Device Publish Date2016-09-22

On-Brand Devices [ColpotomizOR Tube]

0934996700029845mm diameter trans-vaginal tube
0934996700026735mm diameter trans-vaginal tube

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.