DEVICE: Acessa Pads (00854763006102)
Device Identifier (DI) Information
Acessa Pads
3000
In Commercial Distribution
ACESSA HEALTH INC.
3000
In Commercial Distribution
ACESSA HEALTH INC.
Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu Console
Legacy #854763006010
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
---|---|---|---|---|
57972 | Radio-frequency ablation system |
An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) |
OEW | Tracking, Soft Tissue, Intraoperative |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
ITX | Transducer, Ultrasonic, Diagnostic |
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
211ab9b3-f8a4-4323-8624-7dcbcdd5011c
March 02, 2021
3
October 11, 2018
March 02, 2021
3
October 11, 2018
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