Catalog Number

-

Brand Name

ISE Buffer (IS)

Version/Model Number

781611334

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PPM

Product Code Name

General Purpose Reagent

Public Device Record Key

d2306d3a-29a7-45e9-a305-4086998d8978

Public Version Date

December 07, 2020

Public Version Number

3

DI Record Publish Date

October 09, 2020

Package DI Number

14987762129756

Quantity per Package

5

Contains DI Package

04987762129759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-