DEVICE: Reprocessed EFLEX Ablator Probe (B39072096661)
Device Identifier (DI) Information
Reprocessed EFLEX Ablator Probe
7209666
Not in Commercial Distribution
SURETEK MEDICAL
7209666
Not in Commercial Distribution
SURETEK MEDICAL
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
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61815 | Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed |
A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, probe with controls) and requires a patient contact return electrode to complete the circuit. This is a previously used single-use device that has been processed for an additional single-use patient application.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K052692 | 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
cac4c219-2583-42f8-a98c-7b87187d31ef
November 09, 2018
4
September 23, 2016
November 09, 2018
4
September 23, 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