Gems Blastocyst Medium - The Gems Blastocyst Medium is intended for - GENEA BIOMEDX PTY LTD

Duns Number:752103403

Device Description: The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blast The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blastulationstage and transfer of embryos to the uterus.

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More Product Details

Catalog Number

-

Brand Name

Gems Blastocyst Medium

Version/Model Number

BLM-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K161261

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

82915910-5b79-4228-94cf-10267cd0fa2a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENEA BIOMEDX PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 14