Catalog Number

-

Brand Name

ENTity XL Nasopharyngoscope

Version/Model Number

F014721

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 23, 2020

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

K080622

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Public Device Record Key

9428d2a6-137d-4d80-b58c-8824febc0dfb

Public Version Date

April 24, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-