LLD™ #2

Basic Information

• Brand Name: LLD™ #2
• Primary DI: 00813132020774
• Version / Model: 518-022AA
• Catalog Number: 518-022
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-06
• Public Version: 4
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: efc8c248-5187-46f1-946e-fdde65ae3951

Device Description

Lead Locking Device (LLD™ #2)

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRB	Stylet, Catheter	Cardiovascular	870.1380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47046	Pacing/defibrillation lead stylet, extraction	A sterile device designed to remove from the body the electrically-conducting leads (hollow coil type) of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). 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 a working length of 70 cm). It is inserted into the central lumen of the cardiac lead where its locking mechanism is activated to attach it to the lead, whereupon the lead can be pulled free (extracted). It may also be used to extract an indwelling catheter or other foreign object. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M204518022AA0	HIBCC
Primary	00813132020774	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K043401	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit