Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

10-2178

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

DWO

Product Code Name

Needle, Biopsy, Cardiovascular

Public Device Record Key

8cd228b8-5c1c-4794-9b61-e588b9e2ea1c

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

20811870035542

Quantity per Package

20

Contains DI Package

00811870035548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA