Catalog Number

-

Brand Name

RHINO-LARYNGO VIDEOSCOPE

Version/Model Number

OLYMPUS ENF-V4

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

K182102

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Public Device Record Key

d172b32f-a9e8-4557-a1d9-401a2bdecabf

Public Version Date

December 15, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-