Radial Artery Access Introducer Set CLI-424-05

GUDID 20841268104116

Radial Artery Access Introducer Set

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268104116
• NIH Device Record Key: 0eb9a9a5-73d8-4485-81a0-01190b675914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radial Artery Access Introducer Set
• Version Model Number: CLI-424-05
• Catalog Number: CLI-424-05
• 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

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268104112 [Primary]
GS1	10841268104119 [Package]; Contains: 00841268104112; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20841268104116 [Package]; Contains: 10841268104119; Package: Shipper Box [50 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

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

[20841268104116]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-02-26

On-Brand Devices [Radial Artery Access Introducer Set]

• 20841268104130: Radial Artery Access Introducer Set
• 20841268104123: Radial Artery Access Introducer Set
• 20841268104116: Radial Artery Access Introducer Set
• 20841268104109: Radial Artery Access Introducer Set
• 20841268104093: Radial Artery Access Introducer Set
• 20841268104086: Radial Artery Access Introducer Set
• 20841268104079: Radial Artery Access Introducer Set
• 20841268104062: Radial Artery Access Introducer Set
• 20841268104055: Radial Artery Access Introducer Set
• 20841268104048: Radial Artery Access Introducer Set
• 20841268104031: Radial Artery Access Introducer Set
• 20841268104024: Radial Artery Access Introducer Set
• 20841268104017: Radial Artery Access Introducer Set
• 20841268104000: Radial Artery Access Introducer Set
• 20841268103997: Radial Artery Access Introducer Set
• 20841268103980: Radial Artery Access Introducer Set
• 20841268103973: Radial Artery Access Introducer Set
• 20841268103966: Radial Artery Access Introducer Set