Catalog Number

-

Brand Name

Key Surgical Air/Water Tubing

Version/Model Number

EN10902B

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

K191366,K191366

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

20fed69f-926d-40bd-93ce-90dbddede522

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 24, 2021

Package DI Number

00849771041351

Quantity per Package

10

Contains DI Package

00849771041344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box