InnerView® System Handpiece INV-1000

GUDID 00860011518303

QPD Measurement Instrument

Perimetrics, Inc.

Dental stability percussive analysis handpiece

• Primary Device ID: 00860011518303
• NIH Device Record Key: ccae0bbb-4eed-4e38-bdbc-158b93ed0c2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnerView® System Handpiece
• Version Model Number: INV-1000
• Catalog Number: INV-1000
• Company DUNS: 036802075
• Company Name: Perimetrics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx
• Phone: 1-888-325-7218
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011518303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232657

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by Perimetrics, Inc.

• 10860011518324 - InnerView® System Disposable Tips: 2025-04-10 Non-sterile, single-use disposable tips intended for use with InnerView System Handpiece.
• 00860011518303 - InnerView® System Handpiece: 2025-03-13QPD Measurement Instrument
• 00860011518303 - InnerView® System Handpiece: 2025-03-13 QPD Measurement Instrument
• 00860011518310 - InnerView® System Base Station: 2025-03-13 InnerView System Base Station
• 10086001151832 - InnerView® System Disposable Tips: 2025-03-13 Non-sterile, single use disposable tips intended for use with InnerView System Handpiece.