Introducer Needle

Basic Information

• Brand Name: Introducer Needle
• Primary DI: 10801741075343
• Version / Model: S03118-275W
• Catalog Number: S03118-275W
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 69c5da21-6160-44c4-9a2f-a3397549b333

Device Description

SecureLoc 18G x 2.75 inch

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
61502	Vascular catheter introduction needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801741075343	GS1
Unit of Use	00801741075346	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge
Length	2.75	Inch