NOGA XP - NOGA XP-Cardiac Mapping System - BIOSENSE WEBSTER (ISRAEL) LTD.

Duns Number:514556950

Device Description: NOGA XP-Cardiac Mapping System

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More Product Details

Catalog Number

FG170000

Brand Name

NOGA XP

Version/Model Number

FG170000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2020

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQK

Product Code Name

COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Record Status

Public Device Record Key

098c5932-075c-4a17-814a-12eb3e19d327

Public Version Date

October 15, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOSENSE WEBSTER (ISRAEL) LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4