Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS2001

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

FMA

Product Code Name

Depressor, Tongue, Non-Surgical

Public Device Record Key

ab25597f-e237-4ba8-8b1f-9a9395673282

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

10849027002102

Quantity per Package

10

Contains DI Package

00849027002105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case