FDA.reportPublic FDA data

NA

Primary DI
00802526623400
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6946
Catalog number
6946
Device description
Lead Repair Kit
Published
2024-08-29
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

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910073174
P910073175
P910073188

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910073174ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073175ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073188ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526623400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526623400008025266234008025266234000802526623400

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead repair toolA dedicated device used to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). It is typically designed as a small wrench or screwdriver, and is typically used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a reusable device.

Regulatory Flags#

DUNS number
106295384
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
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24
08714729776680Contour™M0061802301802015-09-24
08714729777137Polaris™ UltraM0061921401802015-09-24
08714729777199Polaris™ UltraM0061921501802015-09-24
08714729777205Polaris™ UltraM0061921511802015-09-24
08714729777441Polaris™ LoopM0061552250902015-09-24

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04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
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