V files

GUDID 04560264563001

NAKANISHI INC.

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

• Primary Device ID: 04560264563001
• NIH Device Record Key: 9935b3f7-13ec-4372-b43f-6e6ca808a5cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V files
• Version Model Number: V-U35
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 6
• 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	04560264563001 [Primary]
GS1	04560264565302 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991021

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

[04560264563001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-16

On-Brand Devices [V files]

• 04560264563001: V-U35
• 04560264562998: V-U30
• 04560264562981: V-U25
• 04560264562974: V-U20
• 04560264562967: V-U15