Catalog Number

05424542001

Brand Name

ULTRA Cell Conditioning Solution (ULTRA CC2)

Version/Model Number

05424542001

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

-

Product Code

JCC

Product Code Name

pH buffer

Public Device Record Key

3d6f7902-bfd9-4107-a547-07300955fe73

Public Version Date

June 18, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-