LLD™E 518-039

GUDID M2045180391

Lead Locking Device (LLD E)

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 ID	M2045180391
NIH Device Record Key	7420fe9b-de86-4b15-b43a-4e666bb3920b
Commercial Distribution Discontinuation	2019-02-06
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	LLD™E
Version Model Number	518-039
Catalog Number	518-039
Company DUNS	151047370
Company Name	Spectranetics Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com
Phone	1-800-633-0968
Email	complaints@spnc.com

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2045180390 [Primary]
HIBCC	M2045180391 [Package] Contains: M2045180390 Package: Box [3 Units] Discontinued: 2019-02-06 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K043401

FDA Product Code

DRB	Stylet, Catheter

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[M2045180391]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

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Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

[M2045180391]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-10-26
Device Publish Date	2014-08-19

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