Catalog Number

-

Brand Name

MEM Earles

Version/Model Number

61100061

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 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

KIT

Product Code Name

MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE

Public Device Record Key

cc49cb29-e1a4-4b4c-9326-0b8398ade04b

Public Version Date

December 12, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-