Catalog Number

352257S

Brand Name

NA

Version/Model Number

352.257S

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

K013527,K111437,K042899

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

bc9e7e81-4616-4a9d-bdf4-6e279d8b537a

Public Version Date

May 02, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-