Catalog Number

C45-TV

Brand Name

ColpotomizOR Tube

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

b00e96fb-0f0f-43f6-8a9b-ff13ce843fa7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

09349967000298

Quantity per Package

3

Contains DI Package

09349967000281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton