NiCore Nitinol Guidewire

Basic Information

• Brand Name: NiCore Nitinol Guidewire
• Primary DI: 00801741051500
• Version / Model: 150NSA35
• Catalog Number: 150NSA35
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: ec8176f8-6131-48d9-9275-4021b43f5653

Device Description

NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Stiff Shaft, Angle Tip, 0.035"(0.888mm) x 150cm

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZB	STYLET FOR CATHETER, GASTRO-UROLOGY	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46691	Gastro-urological guidewire, single-use	A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741051507	GS1	CA	10	In Commercial Distribution
Primary	00801741051500	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	150	Centimeter
Outer Diameter	.035	Inch