Lead Cutter™ 518-024

GUDID M204518024AA0

Lead Cutter™

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: M204518024AA0
• NIH Device Record Key: 688c562b-d78d-4f31-8ea5-fac46e859a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lead Cutter™
• Version Model Number: 518-024AA
• Catalog Number: 518-024
• 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: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• Email: complaints@spnc.com
• Phone: 1-800-633-0966
• 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
• 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	00813132020804 [Primary]
HIBCC	M204518024AA0 [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

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

Ethylene Oxide

[M204518024AA0]

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

On-Brand Devices [Lead Cutter™]

• M204518024AA0: Lead Cutter™
• M2045180240: Lead Cutter™