Catalog Number

1227-4

Brand Name

Labtron

Version/Model Number

1227-4

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

48dbe1da-a92d-4454-829c-398f27414faa

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

September 22, 2020

Package DI Number

M368122742

Quantity per Package

10

Contains DI Package

M368122741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box