Catalog Number

-

Brand Name

RapidVit Oocyte

Version/Model Number

10121

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183486

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

e0e2e219-7001-400d-89ed-d2fa4768e660

Public Version Date

March 31, 2021

Public Version Number

3

DI Record Publish Date

December 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-