Catalog Number

7035

Brand Name

CryoSC-Db Seal positioner

Version/Model Number

CryoSC-Db Seal positioner

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK090037

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

183abc6f-23f2-4072-b2b4-34f818b74e0c

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-