Catalog Number

72200869

Brand Name

Y-Adaptor, Inflow Tube Set

Version/Model Number

72200869

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

K000153,K000153

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

ed83ddb9-67f0-4af5-851d-70218b0adf8b

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2015

Package DI Number

23596010655886

Quantity per Package

10

Contains DI Package

03596010655882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX