Catalog Number

IBI-85786

Brand Name

SJM™

Version/Model Number

IBI-85786

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P060019

Product Code

OAD

Product Code Name

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

Public Device Record Key

a717f41c-e289-4bbe-9b86-f1d2e76c1fdd

Public Version Date

January 28, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-