NA

Basic Information

• Brand Name: NA
• Primary DI: 00802526489235
• Version / Model: 6504
• 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: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: ace1d544-69f6-47f2-b8d7-0413023c6a82

Device Description

Lead Cap

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
46222	Pacing/defibrillation lead cap kit	A collection of various implantable pacing lead caps designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals that are not used. This device provides the surgeon with a selection of various size lead caps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526489235	GS1

Premarket Submissions

Submission Number	Supplement Number
P910077	133
P910077	142
P910077	153

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.75 mm Diameter
Device Size Text, specify			3.2 mm Diameter