ELCA

Basic Information

• Brand Name: ELCA
• Primary DI: 00813132025403
• Version / Model: 120-009AB
• Catalog Number: 120-009
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-04
• Public Version: 5
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: edb52274-8e21-469d-92f3-ea2fbf167663

Device Description

ELCA Coronary Laser Atherectomy Catheter

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
LPC	Device, Angioplasty, Laser, Coronary	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
17185	Atherectomy laser system beam guide-catheter, coronary	A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the coronary arteries for the ablation of atherosclerotic plaques in completely occluded vessels. It typically consists of fibreoptic materials with a laser-firing distal end and allows the treatment to be made without significant thermal effect. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813132025403	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.0	Millimeter
Length	135	Centimeter

Storage Conditions

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