Catalog Number

-

Brand Name

Silicone Birth Vac Cup

Version/Model Number

1300-0050

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021193

Product Code

HDB

Product Code Name

Extractor, Vacuum, Fetal

Public Device Record Key

105ca7c6-fe44-4674-941b-d14cf83b3692

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

March 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-