iCare

GUDID 04560264539013

NAKANISHI INC.

Dental handpiece maintenance unit

• Primary Device ID: 04560264539013
• NIH Device Record Key: f209b639-8d82-48d1-b6b9-d9109286fa39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCare
• Version Model Number: iCare C3 Type (120V)
• 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	04560264539013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081811

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: 2020-06-29
• Device Publish Date: 2020-06-19

On-Brand Devices [iCare]

• 04560264539013: iCare C3 Type (120V)
• 04560264538986: iCare C2 Type (120V)