Micro-Introducer Kit KIT-002-01

GUDID 20841268104611

Micro-Introducer Kit

GALT MEDICAL CORP.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20841268104611
• NIH Device Record Key: 717e5b5f-13f6-4864-8245-3f6187d3f42a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Introducer Kit
• Version Model Number: KIT-002-01
• Catalog Number: KIT-002-01
• Company DUNS: 943156836
• Company Name: GALT MEDICAL CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268104617 [Primary]
GS1	10841268104614 [Package]; Contains: 00841268104617; Package: Shel Box [10 Units]; In Commercial Distribution
GS1	20841268104611 [Package]; Contains: 10841268104614; Package: Shippre Box [100 Units]; In Commercial Distribution

FDA Product Code

• OFL: Percutaneous Sheath Introducer Kit

Sterilization

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

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

[20841268104611]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-04

On-Brand Devices [Micro-Introducer Kit]

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• 20841268108701: Micro-Introducer Kit
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• 20841268107209: Micro-Introducer Kit
• 20841268107193: Micro-Introducer Kit
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• 20841268104901: Micro-Introducer Kit
• 20841268104895: Micro-Introducer Kit
• 20841268104888: Micro-Introducer Kit
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• 20841268104819: Micro-Introducer Kit
• 20841268104802: Micro-Introducer Kit
• 20841268104796: Micro-Introducer Kit
• 20841268104789: Micro-Introducer Kit
• 20841268104772: Micro-Introducer Kit
• 20841268104765: Micro-Introducer Kit
• 20841268104758: Micro-Introducer Kit
• 20841268104741: Micro-Introducer Kit
• 20841268104734: Micro-Introducer Kit
• 20841268104727: Micro-Introducer Kit
• 20841268104710: Micro-Introducer Kit
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• 20841268104697: Micro-Introducer Kit
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• 20841268104628: Micro-Introducer Kit
• 20841268104611: Micro-Introducer Kit
• 20841268104604: MIcro-Introducer Kit
• 20841268104420: Micro-Introducer Kit
• 20841268102815: Micro-Introducer Kit
• 20841268102808: Micro-Introducer Kit
• 10841268109619: Micro-Introducer Kit