Catalog Number

-

Brand Name

Intelli-C Accessory

Version/Model Number

03282000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 11, 2022

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

K173631

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

8d8b8e86-a556-443f-b904-2ab53c89954f

Public Version Date

April 12, 2022

Public Version Number

2

DI Record Publish Date

January 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-