Catalog Number

-

Brand Name

SMR MAXI CABINET, ALUMINUM COMPOSITE, STANDARD-TALL, CORDED OTOSCOPES, CANADA

Version/Model Number

S 376000D

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

ETF

Product Code Name

Unit, Examining/Treatment, Ent

Public Device Record Key

ee9ff7f8-2a75-4103-8199-1aa6e37fcbf7

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-