Micro-Access Elite HV Introducer Set CLI-101-26

GUDID 20841268108756

Micro-Access Elite HV Introducer Set

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268108756
• NIH Device Record Key: d181eeb7-e97a-474e-8cd7-7c15c6cd7744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Access Elite HV Introducer Set
• Version Model Number: CLI-101-26
• Catalog Number: CLI-101-26
• 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: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268108752 [Primary]
GS1	10841268108759 [Package]; Contains: 00841268108752; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20841268108756 [Package]; Contains: 10841268108759; 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

[20841268108756]

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: 2019-05-23

On-Brand Devices [Micro-Access Elite HV Introducer Set]

• 20841268108756: Micro-Access Elite HV Introducer Set
• 20841268108749: Micro-Access Elite HV Introducer Set
• 20841268106851: Micro-Access Elite HV Introducer Set
• 20841268103553: Micro-Access Elite HV Introducer Set
• 20841268103546: Micro-Access Elite HV Introducer Set
• 20841268103539: Micro-Access Elite HV Introducer Set
• 20841268103522: Micro-Access Elite HV Introducer Set
• 20841268103515: Micro-Access Elite HV Introducer Set
• 20841268103508: Micro-Access Elite HV Introducer Set
• 20841268103492: Micro-Access Elite HV Introducer Set
• 20841268103485: Micro-Access Elite HV Introducer Set
• 20841268103478: Micro-Access Elite HV Introducer Set
• 20841268103461: Micro-Access Elite HV Introducer Set
• 20841268103454: Micro-Access Elite HV Introducer Set
• 20841268103324: Micro-Access Elite HV Introducer Set
• 20841268103317: Micro-Access Elite HV Introducer Set
• 20841268103300: Micro-Access Elite HV Introducer Set
• 20841268103294: Micro-Access Elite HV Introducer Set
• 20841268103287: Micro-Access Elite HV Introducer Set
• 20841268103270: Micro-Access Elite HV Introducer Set
• 20841268103263: Micro-Access Elite HV Introducer Set
• 20841268103256: Micro-Access Elite HV Introducer Set
• 20841268103249: Micro-Access Elite HV Introducer Set
• 20841268103232: Micro-Access Elite HV Introducer Set
• 20841268103225: Micro-Access Elite HV Introducer Set
• 20841268103218: Micro-Access Elite HV Introducer Set
• 20841268103201: Micro-Access Elite HV Introducer Set
• 20841268103195: Micro-Access Elite HV Introducer Set
• 20841268103188: Micro-Access Elite HV Introducer Set
• 20841268103171: Micro-Access Elite HV Introducer Set