FDA.reportPublic FDA data

SureLead

Primary DI
B631DLSGGE5PL3M1
Brand
SureLead
Company
Authentic Medical
Model
DLSGGE5PL3M
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B631DLSGGE5PL3M1PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078861998
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B631ADSP2PH51SureleadADSP2PH52026-10-07
B631TCDR2GE510C1SureleadTCDR2GE510C2026-10-07
B631TCDRN52MRT510C1SureleadTCDRN52MRT510C2026-10-07
B631TCMXAS4C1SureleadTCMXAS4C2026-10-07
B631TCZLX2PH53M1SureleadTCZLX2PH53M2026-10-07
B631TCSP2PH123M1SureleadTCSP2PH123M2026-10-01
B631DLSRPHP5L6F1SureLeadDLSRPHP5L6F2026-05-19
B631ADX2GE61SureleadADX2GE62026-03-13
B631DLSRPHP5L4F1SureLeadDLSRPHP5L4F2026-03-13
B631EXTGE6PL8F1SureleadEXTGE6PL8F2026-03-13
B631TCGE2GE63M1SureleadTCGE2GE63M2026-03-13
B631TCPH2GE123M1SureleadTCPH2GE123M2025-01-28
B631ADGE2PH55SureleadADGE2PH552025-01-07
B631DLSRGE51M1SureLeadDLSRGE51M2024-11-25
B631DLSRGE53M1SureLeadDLSRGE53M2024-11-25
B631SPPDA1M1SureLeadSPPDA1M2024-11-05
B631TC400MR101SureLeadTC400MR102024-11-05
B631TSC101SureLeadTSC102024-11-05
B631TSC400101SureLeadTSC400102024-11-05
B631ADGE2PH51SureleadADGE2PH52024-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607451FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
06944413830585ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830592ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830608ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830615ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830622ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830639ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830646ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830653ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830660ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830677ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830684ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830691ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830707ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830714ECG CableEdan Instruments, Inc.DSA2026-11-02
G662ME550W1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028G1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028J1MaguireMaguire Enterprises, Inc.DSA2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19