Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

07-PK813

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JAA

Product Code Name

System, x-ray, fluoroscopic, image-intensified

Public Device Record Key

0e8dfec8-2e94-4188-bb12-0435d003336f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 05, 2016

Package DI Number

10848340008846

Quantity per Package

10

Contains DI Package

00848340008849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-