FDA.reportPublic FDA data

INTELLAGEN™ Remote Control

Primary DI
04260166374100
Brand
INTELLAGEN™ Remote Control
Company
Stockert GmbH
Model
20406
Catalog number
M004GEN100204030
Device description
Only commercialized as part of the kit
Published
2024-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPBCardiac Ablation Percutaneous Catheter
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260166374100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260166374100042601663741004260166374100

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system generatorAn electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-272-1001CETechSupportUSA@bsci.com

Regulatory Flags#

DUNS number
327536314
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260166374346INTELLAGEN™ Tubing Set20626206262024-09-01
04260166373066INTELLAGEN™ Foot Pedal20010M004GEN1002001002024-09-01
04260166373080INTELLAGEN™ Grounding Cable (3m)19943M004GEN1001994302024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)19947M004GEN1001994702024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)19949M004GEN1001994902024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)19948M004GEN1001994802024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)19944M004GEN1001994402024-09-01
04260166373134INTELLAGEN™ Irrigation Pump Connection Cable (5m)19946M004GEN1001994602024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)19951M004GEN1001995102024-09-01
04260166373165INTELLAGEN™ lntravenous (IV) Pole Clamp19945M004GEN1001994502024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)20072M004GEN1002007202024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)20075M004GEN1002007502024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)20078M004GEN1002007802024-09-01
04260166373240INTELLAGEN™ Irrigation Pump Connection Cable (1m)20081M004GEN1002008102024-09-01
04260166373257INTELLAGEN™ Irrigation Pump Connection Cable (3m)20084M004GEN1002008402024-09-01
04260166373264INTELLAGEN™ Irrigation Pump Connection Cable (10m)20087M004GEN1002008702024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)20090M004GEN1002009002024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)20094M004GEN1002009402024-09-01
04260166374063INTELLAGEN™ RF Generator20404M004GEN1002040102024-09-01
04260166374070INTELLAGEN™ RF Generator Kit20401M004GEN1002040102024-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
04044508136959MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137031iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
20763000995007N/AMEDTRONIC, INC.OAD2025-04-12
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAD2025-01-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAD2024-12-06
00763000871772NAMEDTRONIC, INC.OAD2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAD2024-11-04
20763000871776NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2024-11-04