FINELINE® II Sterox

Primary DI
00802526060915
Brand
FINELINE® II Sterox
Company
BOSTON SCIENTIFIC CORPORATION
Model
4457
Device description
Sterox Bipolar IS-1 Ventricular
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
P960004039
P960004042
P960004059
P960004060
P960004078
P960004085
P960004088
P960004109
P960004112
P960004113

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960004039THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004042THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004059THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004060THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004078THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004085THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004088THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004109THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004112THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN
P960004113THINLINE ENDOCARDIAL PACING LEADSBoston Scientific1996-11-12NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526060915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526060915008025260609158025260609150802526060915

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

Regulatory Flags#

DUNS number
106295384
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24
00802526488900NA60402014-09-24
00802526488924NA60422014-09-24
00802526488931NA60432014-09-24
00802526496868RELIANCE 4-FRONT™06362018-08-25
00802526496967RELIANCE 4-FRONT™06652018-08-25
00802526496981RELIANCE 4-FRONT™06752018-08-25
00802526497001RELIANCE 4-FRONT™06762018-08-25
00802526523304INGEVITY™ MRI77312016-05-10

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