Catalog Number

IBI-81684

Brand Name

Inquiry™

Version/Model Number

AFocus II™

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010471

Product Code

DRF

Product Code Name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Public Device Record Key

1e8901b4-98de-427d-b26f-42b0ba72a3b1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-