Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS1008A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Public Device Record Key

f50c2d01-4409-4299-9ed5-8a01c9c8c5ec

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

December 31, 2019

Package DI Number

10849027002003

Quantity per Package

10

Contains DI Package

00849027002006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case