Catalog Number

108851

Brand Name

Binocular Indirect Ophthalmoscope

Version/Model Number

IO-a LED BP-II SET2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Public Device Record Key

30b2166d-0ad6-4778-9806-5e017a8bdb93

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-