Catalog Number

-

Brand Name

SynGenX®-1000

Version/Model Number

SGI-0305

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

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

-

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

2e68f3a9-9295-4066-8dd1-b50966182bcd

Public Version Date

October 13, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

B039SGI03051

Quantity per Package

36

Contains DI Package

B039SGI03050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-