Catalog Number

-

Brand Name

BabyDance

Version/Model Number

2

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162319

Product Code

PEB

Product Code Name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Public Device Record Key

a3e7e42c-7f1e-46b6-a1a3-aaf357387995

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

May 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-