ELCA™

Basic Information

• Brand Name: ELCA™
• Primary DI: M2041100020
• Version / Model: 110-002
• Catalog Number: 110-002
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-19
• Public Version: 5
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: 3544d72f-a635-4a69-a7a3-494bedd8db8d
• Distribution End Date: 2019-02-06

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: Yes
• Sterilization Methods: Ethylene Oxide

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	M2041100020	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.97	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit