Catalog Number

-

Brand Name

ColpotomizOR Tube System

Version/Model Number

CTS35-TV

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

f48901a1-4b13-4247-9449-afad98d0eb37

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

09349967003466

Quantity per Package

3

Contains DI Package

09349967003459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper