Catalog Number

W2000C

Brand Name

NA

Version/Model Number

W2000C

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

-

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

K083161,K083161,K083161

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

4f5d9b43-a1f6-4a37-9d42-c1cc35a3ac39

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-