Catalog Number

99275

Brand Name

ISolate® Stock Solution

Version/Model Number

99275-12x6ML

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991341,K991341

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

1345a1d8-95b5-4f06-b5da-3a61cffd3c5f

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

December 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-