Catalog Number

782021

Brand Name

Dealmed

Version/Model Number

782021

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

Yes

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

FMA

Product Code Name

DEPRESSOR, TONGUE, NON-SURGICAL

Public Device Record Key

ecdce0f9-2b86-47ba-a3bb-c5c734a7af87

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

10859140003535

Quantity per Package

10

Contains DI Package

00859140003538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE