VSI Micro-HV Introducer Kit CLI-810-01

GUDID 20841268106615

VSI Micro-HV Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268106615
• NIH Device Record Key: f2f633fc-a4e7-4890-8d76-c50b6321b5d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSI Micro-HV Introducer Kit
• Version Model Number: CLI-810-01
• Catalog Number: CLI-810-01
• 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

Device Dimensions

• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268106611 [Primary]
GS1	10841268106618 [Package]; Contains: 00841268106611; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20841268106615 [Package]; Contains: 10841268106618; 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

[20841268106615]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-05-28

On-Brand Devices [VSI Micro-HV Introducer Kit]

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• 20841268106745: VSI Micro-HV Introducer Kit
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• 20841268106714: VSI Micro-HV Introducer Kit
• 20841268106707: VSI Micro-HV Introducer Kit
• 20841268106691: VSI Micro-HV Introducer Kit
• 20841268106684: VSI Micro-HV Introducer Kit
• 20841268106677: VSI Micro-HV Introducer Kit
• 20841268106660: VSI Micro-HV Introducer Kit
• 20841268106653: VSI Micro-HV Introducer Kit
• 20841268106646: VSI Micro-HV Introducer Kit
• 20841268106639: VSI Micro-HV Introducer Kit
• 20841268106622: VSI Micro-HV Introducer Kit
• 20841268106615: VSI Micro-HV Introducer Kit
• 20841268106608: VSI Micro-HV Introducer Kit
• 20841268106592: VSI Micro-HV Introducer Kit
• 20841268106585: VSI Micro-HV Introducer Kit
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• 20841268106554: VSI Micro-HV Introducer Kit
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• 20841268106530: VSI Micro-HV Introducer Kit
• 20841268106523: VSI Micro-HV Introducer Kit
• 20841268106516: VSI Micro-HV Introducer Kit
• 20841268106509: VSI Micro-HV Introducer Kit
• 20841268106493: VSI Micro-HV Introducer Kit
• 20841268106486: VSI Micro-HV Introducer Kit
• 20841268106479: VSI Micro-HV Introducer Kit
• 20841268106462: VSI Micro-HV Introducer Kit