Catalog Number

-

Brand Name

LABTRON

Version/Model Number

1227-1

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

ERA

Product Code Name

Otoscope

Public Device Record Key

5f9ab933-a792-4b0e-93f8-987730a78fad

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2020

Package DI Number

M368122712

Quantity per Package

20

Contains DI Package

M368122711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box