DEVICE: VersaVue™ Power Cord - US/JP/TW (04719872715252)
Device Identifier (DI) Information
VersaVue™ Power Cord - US/JP/TW
5015
In Commercial Distribution
M0067805010
MEDIMAGING INTEGRATED SOLUTION INC.
5015
In Commercial Distribution
M0067805010
MEDIMAGING INTEGRATED SOLUTION INC.
VersaVue™ Power Cord - US/JP/TW
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? |
|---|---|---|---|---|
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
df4d0bfd-6d6d-4ac3-80db-0f4abe14a147
April 18, 2025
3
October 20, 2023
April 18, 2025
3
October 20, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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
[?]
No Customer Contact currently defined