Varios/VarioSurg/Ti-Max

GUDID 04560264563735

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04560264563735
• NIH Device Record Key: c582b826-8482-4b31-ac32-b9856064b9fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varios/VarioSurg/Ti-Max
• Version Model Number: V-P12
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 3
• DM Exempt: true
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264563735 [Primary]
GS1	04560264565579 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113530

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

[04560264563735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-22
• Device Publish Date: 2016-09-16

On-Brand Devices [Varios/VarioSurg/Ti-Max]

• 04560264563735: V-P12
• 04560264563728: V-P11L
• 04560264563711: V-P11R
• 04560264563339: V-P10