NA

Basic Information

• Brand Name: NA
• Primary DI: 00802526064043
• Version / Model: 6503
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 09842d19-b7a7-4e11-b07c-5158b21cbd89

Device Description

Lead Stabilizer Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWS	Implantable cardioverter defibrillator (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33500	Pacing/defibrillation lead repair kit	A collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526064043	GS1

Premarket Submissions

Submission Number	Supplement Number
P960006	039
P960006	042
P960006	046