Transitionless Radial Access Introducer CLI-225-06

GUDID 20841268108565

Transitionless Radial Access Introducer

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268108565
• NIH Device Record Key: 653ffbcc-d3fd-432c-b987-8fdef9ab903e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transitionless Radial Access Introducer
• Version Model Number: CLI-225-06
• Catalog Number: CLI-225-06
• 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	00841268108561 [Primary]
GS1	10841268108568 [Package]; Contains: 00841268108561; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20841268108565 [Package]; Contains: 10841268108568; 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

[20841268108565]

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 [Transitionless Radial Access Introducer]

• 20841268108671: Transitionless Radial Access Introducer
• 20841268108664: Transitionless Radial Access Introducer
• 20841268108657: Transitionless Radial Access Introducer
• 20841268108640: Transitionless Radial Access Introducer
• 20841268108633: Transitionless Radial Access Introducer
• 20841268108626: Transitionless Radial Access Introducer
• 20841268108619: Transitionless Radial Access Introducer
• 20841268108602: Transitionless Radial Access Introducer
• 20841268108596: Transitionless Radial Access Introducer
• 20841268108589: Transitionless Radial Access Introducer
• 20841268108572: Transitionless Radial Access Introducer
• 20841268108565: Transitionless Radial Access Introducer
• 20841268108558: Transitionless Radial Access Introducer
• 20841268108541: Transitionless Radial Access Introducer
• 20841268108534: Transitionless Radial Access Introducer
• 20841268108527: Transitionless Radial Access Introducer
• 20841268108510: Transitionless Radial Access Introducer
• 20841268108503: Transitionless Radial Access Introducer
• 20841268108497: Transitionless Radial Access Introducer
• 20841268108480: Transitionless Radial Access Introducer
• 20841268108473: Transitionless Radial Access Introducer
• 20841268108466: Transitionless Radial Access Introducer
• 20841268108459: Transitionless Radial Access Introducer
• 20841268108442: Transitionless Radial Access Introducer