LLD™ #1 518-021

GUDID M204518021AB0

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, 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

• Primary Device ID: M204518021AB0
• NIH Device Record Key: 23ed3a81-4434-491d-a017-1f07c834185d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LLD™ #1
• Version Model Number: 518-021AB
• 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

Device Dimensions

• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch
• Outer Diameter: 0.012 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132023003 [Primary]
HIBCC	M204518021AB0 [Secondary]

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

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

[M204518021AB0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

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