Catalog Number

284508

Brand Name

FMS

Version/Model Number

284508

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

K951843,K951843,K951843

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

b81a0d61-f720-4fcd-a4ad-caad71f1a8ec

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

30886705023060

Quantity per Package

12

Contains DI Package

10886705023066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX