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Ulthera System Transducer

FDA UDI

Class II (US FDA UDI)

by Ulthera Inc

Identity

Trade Name
Ulthera System Transducer FDA UDI
Generic Name
Ultrasound hyperthermia system transducer, extracorporeal FDA UDI
Model / Reference
UT-1N Rev. G FDA UDI

Identifiers

Primary DI / UDI-DI
00840763100032 FDA UDI
FDA Product Code
OHV FDA UDI
GMDN Term
Ultrasound hyperthermia system transducer, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4590 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound hyperthermia system transducer, extracorporeal

Ulthera System Transducer by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound hyperthermia system transducer, extracorporeal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulthera Inc

Sources (1)

  • FDA UDI 29407540-1c97-4db6-9612-3743bd3e6d2b 32 fields · synced Jun 1, 2026