Catalog Number

NB-0610-CT

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

NB-0610-CT

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

05e396e8-90d1-47b5-9740-cd7f44569c1c

Public Version Date

January 20, 2022

Public Version Number

1

DI Record Publish Date

January 12, 2022

Package DI Number

20680211002990

Quantity per Package

50

Contains DI Package

00680211002996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX