DEVICE: CoreTherm (07350081910044)
Device Identifier (DI) Information
CoreTherm
Penis Safety Probe
In Commercial Distribution
SP808601
Prostalund AB
Penis Safety Probe
In Commercial Distribution
SP808601
Prostalund AB
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Hyperthermia system temperature probe | A device (a probe) intended to be used exclusively to monitor tissue or body temperature during hyperthermia treatments. Depending on the kind of hyperthermia system it is used with, e.g., ultrasound, radio-frequency (RF) or microwave, this probe is shielded in such a way that its operation is not affected by the energy from the hyperthermia applicator(s) in use during the treatment. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
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MEQ | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P010055 | 009 |
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
56fecc71-3198-4fc3-a1b3-50b5d3ecfce8
July 06, 2018
3
March 07, 2016
July 06, 2018
3
March 07, 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 |
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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