Catalog Number

-

Brand Name

EmbryoAssist

Version/Model Number

12130010D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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

-

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

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

f4408727-1d53-474c-91c2-958491d85a98

Public Version Date

August 29, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

20888937801495

Quantity per Package

10

Contains DI Package

00888937801491

Package Discontinue Date

January 01, 2019

Package Status

Not in Commercial Distribution

Package Type

12131010D 10x10 ml