Catalog Number

-

Brand Name

Double Pump Single/ Double Pump RF Single

Version/Model Number

1002052

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

K093409,K093409,K093409

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

80a9f59d-56a8-4283-87ac-10607700e0d1

Public Version Date

May 27, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

07350021981523

Quantity per Package

2

Contains DI Package

07350021981516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-