Catalog Number

ARC15ST

Brand Name

Arcadia™

Version/Model Number

00884450447192

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

ce8c6130-91ef-4b76-98c2-c690309cdbb0

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

March 26, 2020

Package DI Number

10884450447199

Quantity per Package

16

Contains DI Package

00884450447192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-