FDA.reportPublic FDA data

Solox SLX 58/13-BP

Primary DI
04035479049218
Brand
Solox SLX 58/13-BP
Company
BIOTRONIK SE & Co. KG
Model
333900
Catalog number
333900
Published
2014-08-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTBpermanent pacemaker Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479049218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479049218040354790492184035479049218

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
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
false
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
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20
04035479152406Home Monitoring Service Center3.344193212016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180126Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180133Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180140Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180157Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180249Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180355Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000740252SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2022-12-11
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2022-12-11
00763000740276SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2022-12-11
00763000059477NAMEDTRONIC, INC.DTB2018-12-28
00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2018-10-11
04035479157821EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00763000014636CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20