Catalog Number

485-594

Brand Name

RING TONGUE BLADE

Version/Model Number

485-594

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)

Yes

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

f441681f-0b9b-4ad6-9c6c-4e30cddb8d02

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-