Catalog Number

-

Brand Name

SUCTION/IRRIGATION SHEATH FOR USE WITH SUCTION IRRIGATION HANDLE MODE

Version/Model Number

230859

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 2017

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

6e86ecfe-a6d5-44f8-81bb-eb646cdcf55e

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

May 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-