Catalog Number

1125527

Brand Name

Henry Schein

Version/Model Number

1125527

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

505c8fbb-1b8b-4af8-8d60-44d8f81fa557

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

20304040029194

Quantity per Package

24

Contains DI Package

10304040029197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case