DEVICE: Uro-G Flexible Cystoscope (00860008483706)

Device Identifier (DI) Information

Uro-G Flexible Cystoscope
1520
In Commercial Distribution
1520
UROVIU CORP.
00860008483706
GS1

1
118239699 *Terms of Use
The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
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Device Characteristics

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

GMDN

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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?
61728 Flexible video cystoscope, single-use
A sterile 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 single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
FAJ Cystoscope And Accessories, Flexible/Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K202921 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -10 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1910a91f-cc07-46da-9a47-3e3913566011
December 26, 2022
1
December 16, 2022
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
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Customer Contact

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650 397 5174
cs@uroviu.com
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