Tenex 2nd Generation MicroTip, TXL, 3.0 WL T600-030

GUDID 00857356008767

TRICE MEDICAL, INC.

Hard/soft-tissue ultrasonic surgical system

• Primary Device ID: 00857356008767
• NIH Device Record Key: b9feb9a7-65f2-4a24-9591-fee562dfc3fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenex 2nd Generation MicroTip, TXL, 3.0 WL
• Version Model Number: T600-030
• Catalog Number: T600-030
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00857356008767 [Primary]
GS1	00857356008804 [Package]; Package: Carton [3 Units]; In Commercial Distribution

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: true

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

Devices Manufactured by TRICE MEDICAL, INC.

• 00857356008767 - Tenex 2nd Generation MicroTip, TXL, 3.0 WL: 2025-03-14
• 00857356008767 - Tenex 2nd Generation MicroTip, TXL, 3.0 WL: 2025-03-14
• 00857356008774 - Tenex 2nd Generation MicroTip, TXL+, 2.5 WL: 2025-03-14
• 00857356008781 - Tenex 2nd Generation MicroTip, TXS, 2.0 WL: 2025-03-14
• 00857356008798 - Tenex 2nd Generation MicroTip, TXS+, 1.3 WL: 2025-03-14
• 00857356008842 - Tenex 2nd Generation Console: 2025-03-14
• 00857356008859 - Tenex 2nd Generation Fuse Set: 2025-03-14
• 10861578000376 - mi-eye Procedure Kit 5 pack: 2025-03-03 pack of 5 T900-001
• 00857356008026 - mi-eye 2: 2023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN