FDA.report

Selox

Primary DI
04035479077846
Brand
Selox
Company
BIOTRONIK SE & Co. KG
Model
ST 53
Catalog number
346366
Published
2014-08-06
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

Related Records

Contact Domains

Product Codes

CodeName
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications

CodeDeviceSpecialtyClass
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035479077846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035479077846040354790778464035479077846

GMDN Terms

TermDefinition
Endocardial pacing leadAn implantable flexible 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 also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment Temperature077 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

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04035479188399NEO 2401.U/14928174928172024-12-18
04035479001575M-501121491121492024-10-16
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04035479184636Home Monitoring Service Center3.594860922024-01-10
04035479187163Home Monitoring Service Center3.614906882024-09-03
04035479186005NEO2401.U4883722024-06-17
04035479186012PSW2401.U4883732024-06-17
04035479052515PK-222 US/2,8m3352813352812014-08-20
04035479186128Home Monitoring Service Center3.604886702024-05-29

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