DEVICE: C-VIEW (04048551402481)

Device Identifier (DI) Information

C-VIEW
11272VA
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551402481
GS1

1
315731430 *Terms of Use
CMOS Video Cysto-Urethroscope
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
FBO CYSTOURETHROSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131364 000
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Sterilization

No
Yes
Sterilization Method [?]
Liquid Chemical
Ethylene Oxide
Hydrogen Peroxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f7dd1e56-3392-42b4-aaee-6d46869efc9f
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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