DEVICE: VISERA CYSTO-NEPHRO VIDEOSCOPE (04953170339455)
Device Identifier (DI) Information
VISERA CYSTO-NEPHRO VIDEOSCOPE
OLYMPUS CYF- TYPE VA2
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF- TYPE VA2
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
CYF-VA2 Flex CystoNephro Videoscope wAsp
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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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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46723 | Flexible video cystonephroscope |
An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. It is inserted into the urethra via the natural urinary orifice, or percutaneously into the renal pelvis for the kidneys during endoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is used for the removal/crushing of stones; investigation of pyelitis and renal failure; treatment of lesions of the urinary bladder/posterior urethra; or to evaluate bladder control/incontinence. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NWB | Endoscope, accessories, narrow band spectrum |
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
544e57c1-6d91-43fe-a8b3-96fb287f4d2f
January 16, 2023
4
September 21, 2016
January 16, 2023
4
September 21, 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
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx