Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

VBS-19108

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)

Yes

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

a228e251-e3ca-4b26-b0eb-2720ae989899

Public Version Date

March 15, 2019

Public Version Number

1

DI Record Publish Date

March 07, 2019

Package DI Number

20811870035887

Quantity per Package

10

Contains DI Package

00811870035883

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-