Elite HV Introducer Set CLI-102-41

GUDID 10841268109480

Elite HV® F Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 10841268109480
• NIH Device Record Key: 91695360-a91f-4a7f-8dc5-91f25cf85f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HV Introducer Set
• Version Model Number: CLI-102-41
• Catalog Number: CLI-102-41
• Company DUNS: 943156836
• Company Name: GALT MEDICAL CORP.
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com
• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268109483 [Primary]
GS1	10841268109480 [Package]; Contains: 00841268109483; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20841268109487 [Package]; Package: Shipper Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043525

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

[10841268109480]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-04

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• 10841268109480: Elite HV® F Introducer Kit