Minikut

Basic Information

• Brand Name: Minikut
• Primary DI: 08800069202825
• Version / Model: P910 L35.05
• Catalog Number: 1670535
• Company Name: SURE DENT CORPORATION
• Labeler DUNS: 688273010
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 2
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: 70766d42-ecc5-4a98-a486-cf01dbaa8d06

Device Description

Absorbent Paper Points Taper .05, Size 35, 100/PK, mm marked, SB

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: 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
Unit of Use	88800069202821	GS1
Primary	08800069202825	GS1

Storage Conditions

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