SLS II

Basic Information

• Brand Name: SLS II
• Primary DI: 00813132020316
• Version / Model: 500-013AA
• Catalog Number: 500-013
• 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: 5
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: 1cd507d9-f32a-465a-982e-3c1289e3bf5a

Device Description

SLS II Laser Sheath

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
MFA	Device, Removal, Pacemaker Electrode, Percutaneous	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
45161	Pacing lead extraction kit, single-use	A collection of sterile devices designed to remove the electrically-conducting leads of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), typically in cases where infection has developed or a device malfunction has occurred. It typically includes stylets, dilating sheaths, snares, and retrieval baskets. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M204500013AA0	HIBCC
Primary	00813132020316	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.225	Inch
Length	50	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry