DEVICE: Foot Control 2-pedal (07350021983152)
Device Identifier (DI) Information
Foot Control 2-pedal
1404003
In Commercial Distribution
INSIGHTRA MEDICAL, INC.
1404003
In Commercial Distribution
INSIGHTRA MEDICAL, INC.
For Double Pump RF or Double Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
36336 | Foot-switch, electrical |
An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | Arthroscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K093409 | 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
4e2d84c6-abc5-46f7-b771-15165e14fef8
May 27, 2021
4
September 24, 2016
May 27, 2021
4
September 24, 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