VarioSurg-HP

GUDID 04560264508491

NAKANISHI INC.

Dental ultrasonic surgical system

• Primary Device ID: 04560264508491
• NIH Device Record Key: f3fa4fa2-7184-4aad-945e-10bd3e798f28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VarioSurg-HP
• Version Model Number: VarioSurg-HP
• 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	04560264508491 [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

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

Moist Heat or Steam Sterilization

[04560264508491]

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

Devices Manufactured by NAKANISHI INC.

• 04589551383993 - Bur Stopper: 2024-11-21
• 04589551384006 - Bur Stopper Puller: 2024-11-21
• 04560264502963 - PTL Nozzle: 2024-11-11
• 04560264502970 - EZ-M4 Adaptor: 2024-11-11
• 04589551392063 - EZ SPRAY: 2024-11-11
• 04589551391950 - M205: 2024-10-24
• 04560264578586 - FX204 M4: 2024-10-24
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23