Catalog Number

D160801

Brand Name

VISITAG SURPOINT External Processing Unit

Version/Model Number

D160801

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

P030031

Product Code

OAD

Product Code Name

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

Public Device Record Key

c26526db-d426-4e7f-9062-600f60bae117

Public Version Date

February 10, 2022

Public Version Number

2

DI Record Publish Date

July 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-