DEVICE: VIDEO CYTOSCOPE (04961333232413)
Device Identifier (DI) Information
VIDEO CYTOSCOPE
ECY-P1570K
Not in Commercial Distribution
PENTAX OF AMERICA, INC.
ECY-P1570K
Not in Commercial Distribution
PENTAX OF AMERICA, INC.
VIDEO CYSTOSCOPE (REFURBISHED)
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. 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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44925 | Flexible video cystoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FAJ | Cystoscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K914008 | 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
0de05615-a059-440e-9e6b-be92c93e8a75
July 06, 2018
3
April 06, 2017
July 06, 2018
3
April 06, 2017
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