Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

JBV005

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

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Public Device Record Key

a4cd3f16-3c10-4cf7-9c1c-7747c432b167

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

October 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-