Catalog Number

EGEL48

Brand Name

3 x 4% E-Gel 48 Gels

Version/Model Number

EGEL48

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK050040

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Public Device Record Key

2ce6ac99-76c1-4324-aab9-21eb3eef6697

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-