SmartAblateTM System RF Generator

GUDID 04260166371390

Stockert GmbH

Radio-frequency ablation system generator
Primary Device ID04260166371390
NIH Device Record Keyb6b82fdd-0da4-415c-8208-2351b6a3640e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartAblateTM System RF Generator
Version Model NumberM490007
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
GS104260166371390 [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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