LLD™ #2 518-022

GUDID M204518022AB0

Lead Locking Device (LLD™ #2)

Spectranetics Corporation

Pacing/defibrillation lead stylet, extraction
Primary Device IDM204518022AB0
NIH Device Record Key13cbbedd-4ddc-4b32-80ea-d1a0907ffe3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLLD™ #2
Version Model Number518-022AB
Catalog Number518-022
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

Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone1-800-633-0963
Emailcomplaints@spnc.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Dimensions

Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch
Outer Diameter0.012 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132023027 [Primary]
HIBCCM204518022AB0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRBStylet, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


[M204518022AB0]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-01

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