Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

R1631

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

877cf03c-2287-4e41-8c56-ced1cea5d22f

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

July 27, 2018

Package DI Number

20811870030943

Quantity per Package

12

Contains DI Package

00811870030949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A