Posi-Stick Introducer Set

Basic Information

• Brand Name: Posi-Stick Introducer Set
• Primary DI: H862PS238SW0
• Version / Model: PS2-38SW
• Catalog Number: PS2-38SW
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2019-09-12
• Public Version Status: Update
• Public Device Record Key: e323a802-4055-48cd-bcdd-2be354acb67f
• Distribution End Date: 2019-09-11

Device Description

Posi-Stick Intro. Set w/PT Marker & .038" Super-Stiff GW

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

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	H862PS238SW2	HIBCC	Shipper	1	Not in Commercial Distribution	2019-09-11
Package	H862PS238SW1	HIBCC	Dispenser	10	Not in Commercial Distribution	2019-09-11
Primary	H862PS238SW0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.038	Inch