Varios V-Tip

GUDID 04560264561748

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04560264561748
• NIH Device Record Key: c36f2308-b40b-4294-91f0-e4578b5c6371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varios V-Tip
• Version Model Number: Assorted Tip Kit
• 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: true
• 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	04560264561748 [Primary]

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

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

[04560264561748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Varios V-Tip]

• 04560264562950: Assorted Tip Kit
• 04560264561786: Assorted Tip Kit
• 04560264561748: Assorted Tip Kit