Catalog Number

440-730

Brand Name

Integra® Jarit®

Version/Model Number

440-730

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

K944656,K981751

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

652b1884-9ea0-4798-8b7f-7a7e87a01afa

Public Version Date

February 05, 2020

Public Version Number

5

DI Record Publish Date

August 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-