FDA.reportPublic FDA data

Siello

Primary DI
04035479106232
Brand
Siello
Company
BIOTRONIK SE & Co. KG
Model
JT 45
Catalog number
362703
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479106232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479106232040354791062324035479106232

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial/interventricular septal pacing leadAn implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27
04035479116668Selectra Amplatz 6.0-553755203755202014-08-27
04035479116675Selectra BIO2-453755233755232014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479177041Solia CSP S 60BIOTRONIK SE & Co. KGNVN2026-02-17
04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
08031527019819VegaMICROPORT CRM SRLNVN2023-06-26
08031527019826VegaMICROPORT CRM SRLNVN2023-06-26
08031527019833VegaMICROPORT CRM SRLNVN2023-06-26
08031527019789VegaMICROPORT CRM SRLNVN2023-06-23
08031527019796VegaMICROPORT CRM SRLNVN2023-06-23
08031527019802VegaMICROPORT CRM SRLNVN2023-06-23
05415067046314UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046321UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046338UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046345UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
00763000740252SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
00763000740276SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
05415067037275NAST. JUDE MEDICAL, INC.NVN2022-01-07
00763000316778Adapta™MEDTRONIC, INC.NVN2020-11-28
00802526604430INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604522INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604577INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11