DEVICE: Flex-X (04048551278239)
Device Identifier (DI) Information
Flex-X
11278VU
In Commercial Distribution
Karl Storz GmbH & Co. KG
11278VU
In Commercial Distribution
Karl Storz GmbH & Co. KG
Video Uretero-Renoscope, FLEX-X C
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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38703 | Flexible video ureterorenoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device.
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Active | false |
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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K131369 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Ethylene Oxide |
Hydrogen Peroxide |
Liquid Chemical |
Peracetic Acid |
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
a496452b-9ad2-4ca4-9a30-c26b286e1d01
May 10, 2021
5
September 23, 2016
May 10, 2021
5
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