Quick-Access™ 519-005

GUDID M2045190051

Quick-Access™ Needle Holder

Spectranetics Corporation

Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access kit, single-use

• Primary Device ID: M2045190051
• NIH Device Record Key: 1439cc38-559a-4af3-a017-5287d44cf4f7
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Quick-Access™
• Version Model Number: 519-005
• Catalog Number: 519-005
• 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: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.complaints@spnc.com
• Phone: 1-800-633-0960
• Email: www.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2045190050 [Primary]
HIBCC	M2045190051 [Package]; Contains: M2045190050; Package: Box [5 Units]; Discontinued: 2019-02-06; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112887

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

Ethylene Oxide

[M2045190051]

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: 2014-08-26

On-Brand Devices [Quick-Access™]

• 00813132020736: Quick-Access™ Needle Holder
• M204519001AA0: Quick-Access™ Needle Holder
• M2045190051: Quick-Access™ Needle Holder
• M2045190010: Quick-Access™ Needle Holder