Catalog Number

-

Brand Name

DISTAL-END FLUSHING ADAPTER

Version/Model Number

MAJ-2319

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

K193182

Product Code

OCX

Product Code Name

endoscopic irrigation/suction system

Public Device Record Key

06869a30-8607-4726-96d0-c8a768e0e911

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

January 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-