Catalog Number

TS202VT

Brand Name

CMI

Version/Model Number

Velvet Touch Cup

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HDB

Product Code Name

Extractor, Vacuum, Fetal

Public Device Record Key

b11495cf-2285-49dd-8a9c-d0f2d532e470

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

H671TS202VT1

Quantity per Package

10

Contains DI Package

H671TS202VT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-