SmartAblateTM System Foot Pedal M490005

GUDID 04260166371475

Stockert GmbH

Radio-frequency ablation system generator
Primary Device ID04260166371475
NIH Device Record Key8c795c99-d163-4fda-b700-23f822f185be
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartAblateTM System Foot Pedal
Version Model Number02
Catalog NumberM490005
Company DUNS327536314
Company NameStockert GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260166371475 [Primary]

FDA Product Code

LPBCardiac Ablation Percutaneous Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-11-18

Devices Manufactured by Stockert GmbH

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04260166373103 - INTELLAGEN™ Serial Communication Cable (5m)2024-09-09
04260166373110 - INTELLAGEN™ Serial Communication Cable (15m)2024-09-09
04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m)2024-09-09
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04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m)2024-09-09

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