FDA.reportPublic FDA data

EFH-16

Primary DI
04035479002916
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
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
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
Pacing/defibrillation lead suture sleeveA small, sterile device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is 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 pacemaker or defibrillator system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

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
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180331Sprint 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
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