TOF-D TOF-D

GUDID 03665023000597

Complete ToFscan Kit (TOF-MU, TOF-CHAR_US AC power charger, clamp, TOF-CS1 cable, cable support, user manual)

IDMED

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• Primary Device ID: 03665023000597
• NIH Device Record Key: ad305c80-94d3-4a11-8590-e8a9a4a66f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOF-D
• Version Model Number: TOF-D
• Catalog Number: TOF-D
• Company DUNS: 260233256
• Company Name: IDMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	03665023000597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172690

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2022-06-21
• Device Publish Date: 2022-06-10

Devices Manufactured by IDMED

• 03665023000030 - TOF-MU: 2023-12-18 Main unit ToFscan
• 03665023000122 - TOF-CHAR_US: 2023-12-18 AC Power / Charger (US electrical sockets)
• 03665023000153 - TOF-STICKER1: 2023-12-18 Double-sided stickers for eyebrow sensor (96 units)
• 03665023000344 - TOF-MU: 2023-12-18 Main unit ToFscan
• 03665023000047 - TOF-S2: 2023-03-01 Hand sensor and electrodes connector
• 03665023000078 - TOF-ES: 2023-03-01 Eyebrow sensor and electrodes connector
• 03665023000368 - TOF-DEMO: 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp
• 03665023000375 - TOF-DEMO_F: 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp