SmartAblateTM System Irrigation Pump

GUDID 04260166371093

Stockert GmbH

Surgical irrigation/aspiration system pump
Primary Device ID04260166371093
NIH Device Record Keyadb5849f-6848-4b19-8fa4-93f213144eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartAblateTM System Irrigation Pump
Version Model NumberM490008
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS104260166371093 [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 Date2014-09-23

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04260166373110 - INTELLAGEN™ Serial Communication Cable (15m)2024-09-09
04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m)2024-09-09
04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m)2024-09-09
04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m)2024-09-09

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