Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

D8-10601

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

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

KJG

Product Code Name

Tube, Tissue Culture

Public Device Record Key

1cbb98c5-2fb2-43b2-9af1-95dd5c1c68e4

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 27, 2018

Package DI Number

20811870030882

Quantity per Package

100

Contains DI Package

00811870030888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A