Catalog Number

C-ARM 60M

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

C-ARM 60M

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K863853,K863853,K863853

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

c694f043-2e52-4dff-afc0-b5ec6bfc3d8e

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

10680211003044

Quantity per Package

20

Contains DI Package

00680211003047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX