Catalog Number

-

Brand Name

InfiMed Nexus, DRF, v2.5

Version/Model Number

2.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2017

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

-

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

2e17423b-4351-4461-91d6-975ec56c7357

Public Version Date

December 09, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-