Catalog Number

-

Brand Name

EmbryoAssist

Version/Model Number

12130060D

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

-

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

b79b54cf-2686-4c2a-8ba2-a12f11995b82

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 15, 2016

Package DI Number

20888937801518

Quantity per Package

5

Contains DI Package

00888937801514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

12135060D 5x60 ml