Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

B9-19853

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

82ffd3dc-89d6-47b1-b903-e053268b5adf

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

July 23, 2020

Package DI Number

20811870035153

Quantity per Package

100

Contains DI Package

00811870035159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA