Tenex 2nd Generation Fuse Set 3-10-0529

GUDID 00857356008859

TRICE MEDICAL, INC.

Hard/soft-tissue ultrasonic surgical system

• Primary Device ID: 00857356008859
• NIH Device Record Key: b4fda834-8572-4f9f-b912-3fa6977c4f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenex 2nd Generation Fuse Set
• Version Model Number: 3-10-0529
• Catalog Number: 3-10-0529
• 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: true
• Serial Number: false
• 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	00857356008859 [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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• 00857356008842 - Tenex 2nd Generation Console: 2025-03-14
• 00857356008859 - Tenex 2nd Generation Fuse Set: 2025-03-14
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