DEVICE: SemiFlex Scope (B324MFENDO55LUA10)
Device Identifier (DI) Information
SemiFlex Scope
MF-ENDO 55 LU A1
In Commercial Distribution
MAXIFLEX, LLC
MF-ENDO 55 LU A1
In Commercial Distribution
MAXIFLEX, LLC
55 centimeter limited use endoscope for urological application.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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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36640 | Flexible fibreoptic ureteroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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FGB | Ureteroscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K111480 | 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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Catheter Gauge: 9.5 French |
Length: 55 Centimeter |
Device Record Status
e6151060-446e-4a45-a2f8-0b5a48c921a4
July 06, 2018
3
September 24, 2016
July 06, 2018
3
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
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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