Catalog Number

-

Brand Name

RHINO-LARYNGOFIBERSCOPE

Version/Model Number

OLYMPUS ENF TYPE P4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2022

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

K011869

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Public Device Record Key

e13fc4ad-5569-447c-95dc-4fa1d64f71b7

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

July 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-