Catalog Number

mV-4000

Brand Name

BEAR

Version/Model Number

mV-4000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2020

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

K981751

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Public Device Record Key

dfa68ca1-7bde-44fc-a2dc-fdde7643f0ab

Public Version Date

March 19, 2020

Public Version Number

1

DI Record Publish Date

March 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-