SELDINGER NEEDLE

Basic Information

• Brand Name: SELDINGER NEEDLE
• Primary DI: 00850004162224
• Version / Model: VGSN03A
• Catalog Number: VGSN03A
• Company Name: VALFLUX GROUP, LLC
• Labeler DUNS: 050193715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-19
• Public Version: 1
• Public Version Date: 2019-01-21
• Public Version Status: New
• Public Device Record Key: 83f20f74-9c74-4188-87d3-c3f503b19542

Device Description

VGSN03A SELDINGER NEEDLE WITHOUT WINGS

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: No
• 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
DWO	NEEDLE, BIOPSY, CARDIOVASCULAR	General, Plastic Surgery	878.4800	1

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	00850004162224	GS1

Customer Contacts

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