Catalog Number

IBI-83370

Brand Name

Therapy™

Version/Model Number

Dual-8™

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P040042

Product Code

OAD

Product Code Name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Public Device Record Key

14255928-88e8-4c7a-bccc-c910bc30648d

Public Version Date

January 28, 2019

Public Version Number

3

DI Record Publish Date

September 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-