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

GUDID 10841268108995

Elite HV Transitionless Hemostasis Valve Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve 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

On-Brand Devices [Elite HV Transitionless Hemostasis Valve Introducer Kit]

• 20841268108893: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108886: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108879: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108862: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103959: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103942: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103935: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103928: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103911: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103904: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103898: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103881: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103874: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103867: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103850: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103843: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103836: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103829: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103812: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103805: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103799: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103782: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103775: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103768: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103751: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103744: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103737: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103720: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103713: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103706: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103690: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103683: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103676: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103669: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103652: Elite HV Transitionless Hemostasis Valve Introducer Kits
• 20841268103645: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103638: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103621: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103614: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103607: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103591: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103584: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103577: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103560: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109022: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109015: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109008: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268108995: Elite HV Transitionless Hemostasis Valve Introducer Kit