SX3-MU03

GUDID 04560264566408

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04560264566408
• NIH Device Record Key: 4ee441f4-4865-4cf7-9aca-31cc5f953627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SX3-MU03
• Version Model Number: SX3-MU03
• 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	04560264566408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203791

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

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• 04560264523098 - Primado2: 2024-04-03