FDA.reportPublic FDA data

Si-2

Primary DI
04035479145262
Brand
Si-2
Company
BIOTRONIK SE & Co. KG
Model
106119
Catalog number
106119
Published
2014-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023000PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479000455PackageGS15In Commercial Distribution
04035479145262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479000455040354790004554035479000455
04035479145262040354791452624035479145262

GMDN Terms#

Term, Definition table
TermDefinition
Implantable-device lubricantA friction-reducing substance (e.g., mineral oil) that is primarily used on implantable devices prior to implantation to lubricate surfaces for the promotion of effective function. It is typically used on the pacing leads of implantable pacemakers/defibrillators to lubricate the lead terminal pin to ease its insertion into the header connector (connection socket) of a pulse generator where it is locked into place (some leads have seal rings on the terminal pin which create friction). It is typically supplied in a small disposable tube. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479194192PatientApp 2.10.05319975319972026-07-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812058NAMEDTRONIC, INC.DTB2025-04-12
00763000840259N/AMEDTRONIC, INC.DTB2024-11-14
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
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