InnerView® System Smart Tips

Basic Information

• Brand Name: InnerView® System Smart Tips
• Primary DI: 00860011518334
• Version / Model: INV-3000
• Catalog Number: INV-3000
• Company Name: Perimetrics, Inc.
• Labeler DUNS: 036802075
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2025-07-31
• Public Version: 1
• Public Version Date: 2025-08-08
• Public Version Status: New
• Public Device Record Key: fbf7d52f-9ebf-4df1-92b6-8a3c4461246f

Device Description

Non-sterile, single-use disposable tips intended for use with InnerView System Handpiece.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67339	Dental stability percussive analysis handpiece cover	A device in the form of a thin lid intended to be used as a physical barrier between the patient and the tip of a dental stability percussive analysis handpiece to prevent cross-contamination between patients. It may incorporate a non-powered microchip with a unique security code intended to be read by the handpiece to verify it has not been reused. 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	00860011518327	GS1
Primary	00860011518334	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232657	000