Catalog Number

-

Brand Name

SynGenX®-1000

Version/Model Number

SGI-0046-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

4362df2a-39d6-4cad-b972-e9f1d3008b04

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

B039SGI0046011

Quantity per Package

1

Contains DI Package

B039SGI0046010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-