Vortex and Vortex Blue Absorbent Points

Basic Information

• Brand Name: Vortex and Vortex Blue Absorbent Points
• Primary DI: D716VXAP04451
• Version / Model: VXAP0445
• Catalog Number: VXAP0445
• Company Name: TULSA DENTAL PRODUCTS LLC
• Labeler DUNS: 942778564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-29
• Public Version: 1
• Public Version Date: 2022-09-06
• Public Version Status: New
• Public Device Record Key: 87c81f88-d99f-4fca-9bde-591a101002f5

Device Description

Vortex Ap Points 04/45

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EKN	POINT, PAPER, ENDODONTIC	Dental	872.3830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38777	Endodontic paper point	A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D716VXAP04451	HIBCC