Catalog Number

-

Brand Name

Labtron

Version/Model Number

1227-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

-

Product Code

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Public Device Record Key

43967047-65dc-448f-8ecc-47439ff5c20f

Public Version Date

May 10, 2021

Public Version Number

6

DI Record Publish Date

August 31, 2016

Package DI Number

M368122722

Quantity per Package

20

Contains DI Package

M368122721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box