Posi-Stick Introducer Set

Basic Information

• Brand Name: Posi-Stick Introducer Set
• Primary DI: 00817640020509
• Version / Model: PS2-1S
• Catalog Number: PS2-1S
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-03
• Public Version: 1
• Public Version Date: 2022-06-13
• Public Version Status: New
• Public Device Record Key: 404ab904-bed3-4df1-97f1-f3a7d8fd8c77

Device Description

Posi-Stick One-Step

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: Yes
• 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
KGZ	Accessories, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46448	Fascial tissue dilator, single-use	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817640020506	GS1	Dispenser	5	In Commercial Distribution
Primary	00817640020509	GS1
Package	20817640020503	GS1	Shipper	10	In Commercial Distribution
Previous	H862PS21SNC0	HIBCC

Customer Contacts

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