Catalog Number

3797M

Brand Name

N/A

Version/Model Number

3797M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2021

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

K971253

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

e5674750-805e-40bf-9598-664b29829bcf

Public Version Date

February 15, 2021

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-