iSD900

GUDID 04560264522329

NAKANISHI INC.

Surgical screwdriver, reusable

• Primary Device ID: 04560264522329
• NIH Device Record Key: 398c0d5d-0a24-487f-a0fd-d8ee19bd5f71
• Commercial Distribution Discontinuation: 2022-09-23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSD900
• Version Model Number: Quick Charger for iSD900
• 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	04560264522329 [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: 2022-08-11
• Device Publish Date: 2022-08-03

On-Brand Devices [iSD900]

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