F-Type Adaptor 4H

GUDID 04560264572690

NAKANISHI INC.

Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit Dental handpiece maintenance unit

• Primary Device ID: 04560264572690
• NIH Device Record Key: 9c31e33c-bdb4-4eb9-8ab3-1c4b9257f648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F-Type Adaptor 4H
• Version Model Number: F-Type Adaptor 4H
• 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: 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	04560264572690 [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: 2020-07-06
• Device Publish Date: 2020-06-27

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