Tenex 2nd Generation Console T600-001

GUDID 00857356008842

TRICE MEDICAL, INC.

Hard/soft-tissue ultrasonic surgical system

• Primary Device ID: 00857356008842
• NIH Device Record Key: b934779f-5172-4fb4-8ab3-cc99f43cdce4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenex 2nd Generation Console
• Version Model Number: T600-001
• Catalog Number: T600-001
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, 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: 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	00857356008842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241700

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

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: 2025-03-14
• Device Publish Date: 2025-03-06

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