iSD900

GUDID 04560264521865

NAKANISHI INC.

Surgical screwdriver, reusable Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit Power tool torque control unit

• Primary Device ID: 04560264521865
• NIH Device Record Key: 9f9ae25f-cdce-42f4-b12f-48e166e47df1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSD900
• Version Model Number: iSD900 Motor
• 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	04560264521865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110278

FDA Product Code

• EKX: Handpiece, direct drive, ac-powered

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 [iSD900]

• 04560264521865: iSD900 Motor
• 04560264522329: Quick Charger for iSD900
• 04560264573291: iSD900
• 04560264574212: Quick Charger for iSD900