Guidewire Introducer Needle Guidewire Access Needle

Basic Information

• Brand Name: Guidewire Introducer Needle Guidewire Access Needle
• Primary DI: 00813079021933
• Version / Model: GWI-1802-NS
• Catalog Number: GWI-1802-NS
• Company Name: REMINGTON MEDICAL, INC.
• Labeler DUNS: 788472314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 125
• 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: f41c1a56-10d7-4603-afa9-9d991d29f992

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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	10813079021930	GS1	Shipping Carton	8	In Commercial Distribution
Primary	00813079021933	GS1
Unit of Use	80813079021939	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge