Catalog Number

2C4005

Brand Name

NA

Version/Model Number

2C4005

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"

Yes

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

K960787,K960787

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

a2a15115-f359-4c2d-94a5-9b05f4fd1461

Public Version Date

October 11, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

50085412000973

Quantity per Package

12

Contains DI Package

00085412000978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE