FDA.reportPublic FDA data

Serial Data Com. Cable Recording-/CARTO® Systems

Primary DI
04260166371499
Brand
Serial Data Com. Cable Recording-/CARTO® Systems
Company
Stockert GmbH
Model
M490025
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPBCardiac Ablation Percutaneous Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260166371499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260166371499042601663714994260166371499

GMDN Terms#

Term, Definition table
TermDefinition
Electrical catheter connection cable, reusableAn insulated electrical conductor designed to provide an electrical connection between an electrical catheter (e.g., an electrophysiological diagnostic catheter or ablation catheter) and an electrically-powered parent device (e.g., generator, analyser). Its length may also allow the catheter to remain in the sterile field. This device will be made of robust materials with metal connectors, e.g., gold (Au) plated electrical connecting pins and sockets, that ensure continued reliability each time it is reused. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
327536314
Device count
1
Lot or batch
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
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
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONLPB2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHLPB2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHLPB2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHLPB2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHLPB2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHLPB2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHLPB2024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)Stockert GmbHLPB2024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)Stockert GmbHLPB2024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)Stockert GmbHLPB2024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)Stockert GmbHLPB2024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)Stockert GmbHLPB2024-09-01
04260166374063INTELLAGEN™ RF GeneratorStockert GmbHLPB2024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbHLPB2024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbHLPB2024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbHLPB2024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbHLPB2024-09-01
00763000719265NAMEDTRONIC, INC.LPB2024-08-22
00763000719319NAMEDTRONIC, INC.LPB2024-08-22
00763000593889NAMEDTRONIC, INC.LPB2024-02-17