Catalog Number

A10092

Brand Name

Panoramic Opthalmoscope

Version/Model Number

200Tx

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102492

Product Code

MYC

Product Code Name

Ophthalmoscope,Laser,Scanning

Public Device Record Key

29a4a912-f9ed-4c85-a948-012c6a4d508b

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-