Catalog Number

-

Brand Name

Enhance Water for Tissue Culture

Version/Model Number

15522

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 2020

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

K993140

Product Code

MTW

Product Code Name

System, Water, Reproduction, Assisted, And Purification

Public Device Record Key

fa9612a7-ffbd-475c-9ebe-2c4ebf099001

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

April 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-