Catalog Number

782010

Brand Name

Dealmed

Version/Model Number

782010

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

1d9fa6ac-fe5a-4963-a7e0-acd9b37c1859

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

10859140003511

Quantity per Package

10

Contains DI Package

00859140003514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE