DEVICE: LIPOcel (08800020100009)
Device Identifier (DI) Information
LIPOcel
LIPOcel
In Commercial Distribution
Jeisys Medical Inc.
LIPOcel
In Commercial Distribution
Jeisys Medical Inc.
Focused Ultrasound for tissue heat or mechanical cellular disruption
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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 |
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OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K181896 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fe2108be-46b0-4f60-9c9a-db5c9fa9b8cf
March 04, 2020
1
February 25, 2020
March 04, 2020
1
February 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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