FDA.reportPublic FDA data

NA

Primary DI
00802526489327
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6583
Device description
Straight Lead Stylet Firm
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
DTDpacemaker lead Adaptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTDPacemaker Lead AdaptorCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526489327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526489327008025264893278025264893270802526489327

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead styletA sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812041NAMEDTRONIC, INC.DTD2025-04-12
00885672011222Lead AdaptorOscor Inc.DTD2021-08-16
00763000059460NAMEDTRONIC, INC.DTD2019-05-11
10885672102453Lead AdaptorOscor Inc.DTD2017-11-27
00836559005544Lead AdaptorOscor Inc.DTD2017-11-27
00885672008352Lead AdaptorOscor Inc.DTD2017-11-27
00885672008369Lead AdaptorOscor Inc.DTD2017-11-27
00885672008260IS4/DF4 PlugOscor Inc.DTD2017-11-21
00802526497506Lead AdaptorOscor Inc.DTD2017-11-21
00802526497513Lead AdaptorOscor Inc.DTD2017-11-21
00802526497520Lead AdaptorOscor Inc.DTD2017-11-21
00802526497537Lead AdaptorOscor Inc.DTD2017-11-21
00802526505300LV-1 PlugOscor Inc.DTD2017-11-21
00802526540608VV-PlugOscor Inc.DTD2017-11-21
00885672008277Lead AdaptorOscor Inc.DTD2017-11-15
00885672008284Lead AdaptorOscor Inc.DTD2017-11-15
00885672008291VV-PlugOscor Inc.DTD2017-11-15
00885672008307VV-PlugOscor Inc.DTD2017-11-15
00885672008314LV-1 PlugOscor Inc.DTD2017-11-15
00885672008321Lead AdaptorOscor Inc.DTD2017-11-15
00885672008338Lead AdaptorOscor Inc.DTD2017-11-15
05414734506441SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
05414734506458SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
00836559004752BIS/BLV-13Oscor Inc.DTD2016-11-10
00836559006428Lead Adaptor Bipolar/UnipolarOscor Inc.DTD2016-02-25
00836559006411BLV/BIS-10Oscor Inc.DTD2015-12-29
00836559002611C/IS-10Oscor Inc.DTD2015-10-16
00836559002642M/IS-40Oscor Inc.DTD2015-10-16
00836559002666B/IS-15Oscor Inc.DTD2015-10-16
00836559002680BIS/IS-15Oscor Inc.DTD2015-10-16