Catalog Number

-

Brand Name

N/A

Version/Model Number

100135P

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

Yes

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

K060962,K060962

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

83b49c46-78d0-468f-a5ad-ad436a49ed90

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-