Catalog Number

-

Brand Name

ColpoWave Balloon

Version/Model Number

CBD

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

K161065

Product Code

HEW

Product Code Name

Culdoscope (And Accessories)

Public Device Record Key

8227fbeb-951d-4163-999a-f700914ca81a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-