LLD™ #1 518-021

GUDID M2045180210

Lead Locking Device (LLD #1)

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: M2045180210
• NIH Device Record Key: 47d00113-9525-4bf1-b662-9972b9e010f2
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LLD™ #1
• Version Model Number: 518-021
• Catalog Number: 518-021
• 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: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• Email: complaints@spnc.com
• Phone: 1-800-633-0961
• 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	M2045180210 [Primary]

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

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

Ethylene Oxide

[M2045180210]

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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• 00813132020743: Lead Locking Device (LLD™ #1)
• M2045180210: Lead Locking Device (LLD #1)
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