VarioSurg-HPSC

GUDID 04560264510739

NAKANISHI INC.

Dental ultrasonic surgical system

• Primary Device ID: 04560264510739
• NIH Device Record Key: bf244f7a-6535-47ff-b69f-673ed44b1f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VarioSurg-HPSC
• Version Model Number: VarioSurg-HPSC
• Company DUNS: 690710546
• Company Name: NAKANISHI 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264510739 [Primary]
GS1	04560264557260 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073678

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264510739]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-09-16

On-Brand Devices [VarioSurg-HPSC]

• 04560264560239: VarioSurg-HPSC
• 04560264510739: VarioSurg-HPSC