LLD™ #2 518-019

GUDID M2045180191

Lead Locking Device (LLD #2)

Spectranetics Corporation

Pacing/defibrillation lead stylet, extraction
Primary Device IDM2045180191
NIH Device Record Keyd1a493e8-929d-4a42-85c7-4a74d9c8bb1f
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLLD™ #2
Version Model Number518-019
Catalog Number518-019
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

Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
Emailcomplaints@spnc.com
Phone1-800-633-0962
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
HIBCCM2045180190 [Primary]
HIBCCM2045180191 [Package]
Contains: M2045180190
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

[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


[M2045180191]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [LLD™ #2]

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M204518019AB0Lead Locking Device (LLD™ #2)
M204518022AA0Lead Locking Device (LLD™ #2)
00813132020767Lead Locking Device (LLD™ #2)
M2045180220Lead Locking Device (LLD #2)
M2045180191Lead Locking Device (LLD #2)

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