DEVICE: Exilis large applicator (B108215APLATENUS0)
Device Identifier (DI) Information
Exilis large applicator
215/1
In Commercial Distribution
BTL INDUSTRIES LIMITED
215/1
In Commercial Distribution
BTL INDUSTRIES LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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? |
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40737 | Hyperthermia system gantry |
An integral component of a therapeutic hyperthermia system that typically consists of a stationary stand or frame stabilized by side supports that acts as the primary support and housing for the non-ionizing radiation generating components or assemblies, e.g., ultrasound or radio-frequency (RF), motors and related electronics of a therapeutic hyperthermia configuration. Some hyperthermia gantry designs can incorporate a motorized table for patient support and positioning during treatment. Depending on the design, it can include a variety of other components, e.g., motors, mounts or motion controls.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
8b714063-7b5c-474b-a9a1-90dd096a34dd
March 29, 2018
2
January 12, 2017
March 29, 2018
2
January 12, 2017
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