LLD™ #2 518-022

GUDID M204518022AA0

Lead Locking Device (LLD™ #2)

Spectranetics Corporation

Pacing/defibrillation lead stylet, extraction

• Primary Device ID: M204518022AA0
• NIH Device Record Key: efc8c248-5187-46f1-946e-fdde65ae3951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LLD™ #2
• Version Model Number: 518-022AA
• Catalog Number: 518-022
• 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: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• Email: complaints@spnc.com
• Phone: 1-800-633-0963
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132020774 [Primary]
HIBCC	M204518022AA0 [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

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

Ethylene Oxide

[M204518022AA0]

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: 2015-02-06

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• M2045180191: Lead Locking Device (LLD #2)