DEVICE: Ulthera System Transducer (00840763100049)

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Device Record History
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Device Identifier (DI) Information
Ulthera System Transducer
UT-2 Rev. I
In Commercial Distribution

Ulthera, Inc.
00840763100049
GS1

1
010981554 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
IYO System, Imaging, Pulsed Echo, Ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K134032 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
60e07ae8-1d2b-4c1a-bea7-0ed5c572c122
May 09, 2024
4
December 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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