Catalog Number

IBI-83725

Brand Name

Therapy™

Version/Model Number

IBI-83725

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

P040014

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

aa70afec-9ede-4336-aba5-c183e88ab001

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

-