Paper Points

Basic Information

• Brand Name: Paper Points
• Primary DI: 00195062047329
• Version / Model: 13977
• Company Name: Kerr Corporation
• Labeler DUNS: 199354556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2024-07-08
• Public Version: 1
• Public Version Date: 2024-07-16
• Public Version Status: New
• Public Device Record Key: 649d20f1-80bb-420d-b32c-3a52bf76bfa3

Device Description

Paper Points - # 45

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

Sterilization

• Is Sterile: No
• 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
Unit of Use	00195062047053	GS1
Primary	00195062047329	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambient temperature