Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

B9-19797

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

c5ca76e8-0f58-4fff-8827-058067ee8f17

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 04, 2020

Package DI Number

20811870034682

Quantity per Package

25

Contains DI Package

00811870034688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA