Micro-Access Tearaway Introducer Kit KIT-010-10

GUDID 20841268105175

Micro-Access Tearaway Introducer Kit

GALT MEDICAL CORP.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20841268105175
• NIH Device Record Key: d00860a2-3acf-444b-9d5f-20c14a1239ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Access Tearaway Introducer Kit
• Version Model Number: KIT-010-10
• Catalog Number: KIT-010-10
• 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: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French
• Catheter Gauge: 3 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268105171 [Primary]
GS1	10841268105178 [Package]; Contains: 00841268105171; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20841268105175 [Package]; Contains: 10841268105178; Package: Shipper Box [50 Units]; In Commercial Distribution

FDA Product Code

• OFL: Percutaneous Sheath Introducer Kit

Sterilization

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

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

Ethylene Oxide

[20841268105175]

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: 2018-02-06

On-Brand Devices [Micro-Access Tearaway Introducer Kit]

• 20841268107414: Micro-Access Tearaway Introducer Kit
• 20841268105441: Micro-Access Tearaway Introducer Kit
• 20841268105434: Micro-Access Tearaway Introducer Kit
• 20841268105427: Micro-Access Tearaway Introducer Kit
• 20841268105410: Micro-Access Tearaway Introducer Kit
• 20841268105403: Micro-Access Tearaway Introducer Kit
• 20841268105397: Micro-Access Tearaway Introducer Kit
• 20841268105380: Micro-Access Tearaway Introducer Kit
• 20841268105373: Micro-Access Tearaway Introducer Kit
• 20841268105366: Micro-Access Tearaway Introducer Kit
• 20841268105359: Micro-Access Tearaway Introducer Kit
• 20841268105342: Micro-Access Tearaway Introducer Kit
• 20841268105335: Micro-Access Tearaway Introducer Kit
• 20841268105328: Micro-Access Tearaway Introducer Kit
• 20841268105311: Micro-Access Tearaway Introducer Kit
• 20841268105304: Micro-Access Tearaway Introducer Kit
• 20841268105298: Micro-Access Tearaway Introducer Kit
• 20841268105281: Micro-Access Tearaway Introducer Kit
• 20841268105274: Micro-Access Tearaway Introducer Kit
• 20841268105267: Micro-Access Tearaway Introducer Kit
• 20841268105250: Micro-Access Tearaway Introducer Kit
• 20841268105243: Micro-Access Tearaway Introducer Kit
• 20841268105236: Micro-Access Tearaway Introducer Kit
• 20841268105229: Micro-Access Tearaway Introducer Kit
• 20841268105212: Micro-Access Tearaway Introducer Kit
• 20841268105205: Micro-Access Tearaway Introducer Kit
• 20841268105199: Micro-Access Tearaway Introducer Kit
• 20841268105182: Micro-Access Tearaway Introducer Kit
• 20841268105175: Micro-Access Tearaway Introducer Kit
• 20841268105168: Micro-Access Tearaway Introducer Kit
• 20841268105151: Micro-Access Tearaway Introducer Kit
• 20841268105144: Micro-Access Tearaway Introducer Kit
• 20841268105137: Micro-Access Tearaway Introducer Kit
• 20841268105120: Micro-Access Tearaway Introducer Kit
• 20841268105113: Micro-Access Tearaway Introducer Kit
• 20841268105106: Micro-Access Tearaway Introducer Kit
• 20841268105090: Micro-Access Tearaway Introducer Kit
• 20841268102952: Micro-Access Tearaway Introducer Kit
• 20841268102945: Micro-Access Tearaway Introducer Kit
• 20841268102938: Micro-Access Tearaway Introducer Kit
• 10841268109282: Micro-Access Tearaway Introducer Kit
• 10841268109275: Micro-Access Tearaway Introducer Kit
• 10841268109268: Micro-Access Tearaway Introducer Kit
• 10841268109251: Micro-Access Tearaway Introducer Kit
• 10841268109244: Micro-Access Tearaway Introducer Kit
• 10841268109237: Micro-Access Tearaway Introducer Kit
• 10841268109220: Micro-Access Tearaway Introducer Kit
• 10841268109213: Micro-Access Tearaway Introducer Kit
• 10841268109206: Micro-Access Tearaway Introducer Kit