Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

R1168

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

5d12385b-f51f-4e01-a75f-815800452e0d

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 26, 2018

Package DI Number

20811870030981

Quantity per Package

24

Contains DI Package

00811870030987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A