Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

5222929

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

3e092799-0f0b-4974-b13a-15165886cc3c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 26, 2017

Package DI Number

10848340010207

Quantity per Package

60

Contains DI Package

00848340010200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-