Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-124-14

GUDID 10841268108995

Elite HV Transitionless Hemostasis Valve Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 10841268108995
• NIH Device Record Key: a24f5b0c-7c53-4cd1-a7bc-1c74ffb5fcee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HV Transitionless Hemostasis Valve Introducer Kit
• Version Model Number: CLI-124-14
• Catalog Number: CLI-124-14
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268108998 [Primary]
GS1	10841268108995 [Package]; Contains: 00841268108998; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20841268108992 [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

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

[10841268108995]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-14
• Device Publish Date: 2020-12-04

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