NA

Basic Information

• Brand Name: NA
• Primary DI: 00802526066719
• Version / Model: 6804
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 4
• Public Version Date: 2020-01-15
• Public Version Status: Update
• Public Device Record Key: ba7121a9-49db-4ab8-8380-a1534a7da50c
• Distribution End Date: 2019-01-29

Device Description

Lead Pulling Tip STL IS-1/DF-1

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
60956	Pacing/defibrillation lead tunneller	A sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526066719	GS1

Premarket Submissions

Submission Number	Supplement Number
P910073	036