Radial Artery Access Introducer Set

Basic Information

• Brand Name: Radial Artery Access Introducer Set
• Primary DI: 00841268104136
• Version / Model: CLI-424-07
• Catalog Number: CLI-424-07
• Company Name: GALT MEDICAL CORP.
• Labeler DUNS: 943156836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 5
• Public Version Date: 2020-12-14
• Public Version Status: Update
• Public Device Record Key: 204adfaf-37a2-4030-9b99-f621141d5f2a
• Distribution End Date: 2020-12-11

Device Description

Radial Artery Access Introducer Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36079	Haemostasis valve	A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841268104130	GS1	Shipper Box	50	Not in Commercial Distribution	2020-12-11
Package	10841268104133	GS1	Shelf Box	5	Not in Commercial Distribution	2020-12-11
Primary	00841268104136	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K043525	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	7	French