DEVICE: OES CYSTONEPHROFIBERSCOPE (04953170339417)
Device Identifier (DI) Information
OES CYSTONEPHROFIBERSCOPE
OLYMPUS CYF-5
Not in Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF-5
Not in Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
CYF-5 Flex CystoNephro Fiberscope
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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46722 | Flexible fibreoptic cystonephroscope |
An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). 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 |
FDI | SNARE, FLEXIBLE |
FCL | FORCEPS, BIOPSY, NON-ELECTRIC |
FGA | Kit, nephroscope |
KNS | Unit, electrosurgical, endoscopic (with or without accessories) |
KGE | FORCEPS, BIOPSY, ELECTRIC |
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
374b7b62-f755-45fa-8c48-e6d33d255ee9
January 15, 2024
8
September 21, 2016
January 15, 2024
8
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
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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
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx