DEVICE: Ulthera System Transducer (00840763100346)
Device Identifier (DI) Information
Ulthera System Transducer
UT-4 Rev. G
In Commercial Distribution
Ulthera, Inc.
UT-4 Rev. G
In Commercial Distribution
Ulthera, Inc.
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
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| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 40777 | Ultrasound hyperthermia system transducer, extracorporeal |
An ultrasound (US) transducer assembly that is a component of an ultrasound hyperthermia system used to induce systemic or local body heating of sufficient magnitude to create a targeted therapeutic effect. It is mounted within the gantry or housing of the hyperthermia system or mounted on a floor, wall, or ceiling suspension that allows the operator to position the transducer assembly external to the patient during treatment. It is typically composed of a single transducer element or an array of transducer elements, i.e., piezoelectric or active element(s), or crystal(s) and associated damping, backing, and matching layer materials. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K134032 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
65ad2df0-b325-492c-a90b-4d6210f927f6
May 09, 2024
4
August 12, 2016
May 09, 2024
4
August 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined