Catalog Number

CTS45-TV

Brand Name

ColpotomizOR Tube System

Version/Model Number

45mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HEW

Product Code Name

Culdoscope (And Accessories)

Public Device Record Key

41f57e3b-2200-4133-bc33-edbedb6dfce9

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

09349967000342

Quantity per Package

5

Contains DI Package

09349967000335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box