AS2000 B2/B3

GUDID 04560224977190

NAKANISHI INC.

Pneumatic dental scaling/debridement system handpiece

• Primary Device ID: 04560224977190
• NIH Device Record Key: 662365c3-817d-4f1c-869d-6ba073d32145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AS2000 B2/B3
• Version Model Number: AS2000 B2/B3
• 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	04560224977190 [Primary]
GS1	04560264557376 [Direct Marking]

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

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

[04560224977190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-10
• Device Publish Date: 2016-09-16

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• 04560264578586 - FX204 M4: 2024-10-24
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23