Catalog Number

5680A-349W

Brand Name

Diagnostix.

Version/Model Number

5680A-349W

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

-

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

K081160,K950914

Product Code

ERA

Product Code Name

Otoscope

Public Device Record Key

9b55d480-a6e8-4aa3-be25-0e51c22944c1

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-