Catalog Number

BR946-4070-175

Brand Name

BR Surgical, LLC

Version/Model Number

BR946-4070-175

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Public Device Record Key

cc3b2250-9666-42af-8b5d-5d64fdc35d63

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-