FDA.reportPublic FDA data

SMARTABLATE-SCom. Recording-/CARTO® Cable

Primary DI
04260166371345
Brand
SMARTABLATE-SCom. Recording-/CARTO® Cable
Company
Stockert GmbH
Model
M490023
Device description
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Published
2018-04-27
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
04260166371345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260166371345042601663713454260166371345

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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