FDA.reportPublic FDA data

EFH-16

Primary DI
04035479144821
Brand
EFH-16
Company
BIOTRONIK SE & Co. KG
Model
115489
Catalog number
115489
Published
2014-08-14
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479002916PackageGS110In Commercial Distribution
04035479144821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479002916040354790029164035479002916
04035479144821040354791448214035479144821

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation lead suture sleeveA small device with a hollow centre that functions as a channel for an implantable electrical stimulation lead (e.g., pacing lead, defibrillation lead, neurostimulation lead) intended to be positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the electrical stimulator, pacemaker or defibrillator system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
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
04035479190705NEO 2601.U4991024991022026-09-21
04035479190712PSW 2601.U4991034991032026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812058NAMEDTRONIC, INC.DTB2025-04-12
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180058Sprint 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
00763000180249Sprint Quattro Secure™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
00763000014650CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014674CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014681CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014698CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014704CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00763000014728CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-20
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02
00643169633759CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.DTB2017-06-02