Catalog Number

-

Brand Name

Tube set for C7050 Irrigation Console

Version/Model Number

Z0449-32

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K962114,K962114

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

9af2b271-abdc-4bfa-9d1b-41c4ef83d0a1

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

August 05, 2016

Package DI Number

04056702002220

Quantity per Package

10

Contains DI Package

04056702002213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-