Aurum Pro Absorbent Paper Points, F1

Basic Information

• Brand Name: Aurum Pro Absorbent Paper Points, F1
• Primary DI: 08806387823643
• Version / Model: 2364
• Company Name: Meta Biomed Co., Ltd.
• Labeler DUNS: 688322841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-24
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: a1ac3b5e-5de4-413a-930e-3430071f707e

Device Description

Aurum Pro Absorbent Paper Points, F1, 60 Points, P 71

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

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	08806387823643	GS1