Catalog Number

-

Brand Name

PENTAX LIGHT SOURCE CONNECTOR FOR USE WITH GYRUS ENT FLEXIBLE AND RIG

Version/Model Number

70230946

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 27, 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

K932988

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

abe3013a-c1b6-4792-bb4b-e1def281e6c6

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-