AccessGUDID - DEVICE: ELCA™ (M2041100020)

GUDID

Device Identifier (DI) Information

Brand Name: ELCA™
Version or Model: 110-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 110-002
Company Name: Spectranetics Corporation

Primary DI Number: M2041100020
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: ELCA™ Coronary Laser Atherectomy Catheter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPC	Device, Angioplasty, Laser, Coronary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.97 Millimeter

Device Record Status

Public Device Record Key: 3544d72f-a635-4a69-a7a3-494bedd8db8d
Public Version Date: October 26, 2021
Public Version Number: 5
DI Record Publish Date: August 19, 2014