Guidewire Introducer Needle

Basic Information

• Brand Name: Guidewire Introducer Needle
• Primary DI: 00813079020301
• Version / Model: GWI-1802
• Catalog Number: GWI-1802
• Company Name: REMINGTON MEDICAL, INC.
• Labeler DUNS: 788472314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: bdb757e7-b585-4892-b73d-49ae9144991b

Device Description

18ga (1.3mm) x 7cm

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12747	Intra-arterial needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to puncture an artery. The needle may be heparinized to prevent blood clotting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20813079020305	GS1	Shipping Carton	10	In Commercial Distribution
Package	10813079020308	GS1	Inner Carton	10	In Commercial Distribution
Primary	00813079020301	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge