Tenex 2nd Generation Console

FDA UDI

Class U (US FDA UDI)

by Trice Medical, Inc.

Identity

Trade Name: Tenex 2nd Generation Console FDA UDI
Generic Name: Hard/soft-tissue ultrasonic surgical system FDA UDI
Model / Reference: T600-001 FDA UDI

Identifiers

Catalog Number: T600-001 FDA UDI
Primary DI / UDI-DI: 00857356008842 FDA UDI
510(k) Number: K241700 FDA UDI
FDA Product Code: LFL FDA UDI
GMDN Term: Hard/soft-tissue ultrasonic surgical system FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hard/soft-tissue ultrasonic surgical system

Tenex 2nd Generation Console by Trice Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hard/soft-tissue ultrasonic surgical system.

OSCAR 3 — Orthofix, Inc. · Class II
ACTEON — Satelec · Class II
TORS — RADLEY SCIENTIFIC LIMITED · Class II
ACTEON — Satelec · Class II
OSCAR 3 — Orthofix, Inc. · Class II
ACTEON — Satelec · Class II
Axiom Blades — Peter Brasseler Holdings, LLC · Class II
Piezomed Pro Accessory — W & H Dentalwerk Bürmoos GmbH · Class II

Cleared under the same submission

K241700 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Trice Medical, Inc.

Sources (1)

FDA UDI b934779f-5172-4fb4-8ab3-cc99f43cdce4 34 fields · synced Jun 8, 2026