Surgic Pro

GUDID 04560264560048

NAKANISHI INC.

Dental implant system

• Primary Device ID: 04560264560048
• NIH Device Record Key: 8df5889d-4ee4-4347-b8fe-197f51fca8ae
• Commercial Distribution Discontinuation: 2018-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Surgic Pro
• Version Model Number: Surgic Pro OPT(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	04560264560048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972924

FDA Product Code

• EBW: CONTROLLER, FOOT, HANDPIECE AND CORD

Sterilization

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

[04560264560048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Surgic Pro]

• 04560264560055: Surgic Pro NON-OPT(120V)
• 04560264560048: Surgic Pro OPT(120V)
• 04560264557635: Surgic Pro OPT(230V)
• 04560264557567: Surgic Pro NON-OPT(120V)
• 04560264557550: Surgic Pro OPT(120V)
• 04560264557543: Surgic Pro+ OPT(120V)
• 04560264530287: Surgic Pro NON-OPT(120V)
• 04560264530270: Surgic Pro OPT(120V)
• 04560264527270: Surgic Pro OPT(230V)