Catalog Number

BTS-302

Brand Name

WHITE LIGHT WI-FI DERMATOSCOPE

Version/Model Number

BTS-302

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2022

Issuing Agency

In HIBCC

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

ERA

Product Code Name

Otoscope

Public Device Record Key

c16a57ef-54ed-40fc-a4fa-6fa8034d1439

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-