Tenex 2nd Generation Fuse Set

FDA UDI

Class U (US FDA UDI)

by Trice Medical, Inc.

Identity

Trade Name: Tenex 2nd Generation Fuse Set FDA UDI
Generic Name: Hard/soft-tissue ultrasonic surgical system FDA UDI
Model / Reference: 3-10-0529 FDA UDI

Identifiers

Catalog Number: 3-10-0529 FDA UDI
Primary DI / UDI-DI: 00857356008859 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Hard/soft-tissue ultrasonic surgical system

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

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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

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Manufacturer

Manufacturer: Trice Medical, Inc.

Sources (1)

FDA UDI b4fda834-8572-4f9f-b912-3fa6977c4f7b 34 fields · synced May 31, 2026