LLD™#3 518-020

GUDID M2045180201

Lead Locking Device (LLD #3)

Spectranetics Corporation

Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet, extraction Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet
Primary Device IDM2045180201
NIH Device Record Key17e3d801-9a6b-4dd2-bcde-89883d3fc965
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLLD™#3
Version Model Number518-020
Catalog Number518-020
Company DUNS151047370
Company NameSpectranetics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com
Phone1-800-633-0964
Emailcomplaints@spnc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM2045180200 [Primary]
HIBCCM2045180201 [Package]
Contains: M2045180200
Package: Box [3 Units]
Discontinued: 2019-02-06
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRBStylet, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

[M2045180201]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-10-26
Device Publish Date2014-08-19

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00813132029937 - CVX-3002022-10-20 Excimer Laser System
M2041100010 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100020 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100030 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041100040 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
M2041140090 - ELCA™2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
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