Catalog Number

99275

Brand Name

ISolate® Stock Solution

Version/Model Number

99275-500ML

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991341

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

40dd0210-da3b-4358-8022-d57784df8b13

Public Version Date

April 30, 2021

Public Version Number

6

DI Record Publish Date

September 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-