Device
CFlex™ Single-Use Cystoscope, Reverse Deflection
Manufacturer
Verathon Medical (Canada) ULC
Verathon Medical (Canada) ULC
Model: Single-Use Cystoscope, Reverse Deflection
Catalog: 0570-0459
DI: 00840432200018
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
CFlex™ Single-Use Cystoscope, Reverse Deflection
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5f550bdc-0c6c-4215-bae7-450f9dce639a
Distribution Status:
In Commercial Distribution
DUNS Number:
243738320
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
10840432200015
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00840432200018
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840432200018
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61728
Name: Flexible video cystoscope, single-use
Definition:
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.
FDA Product Codes
FAJ
Cystoscope And Accessories, Flexible/Rigid
Premarket Submissions
Submission Number:
K253696
Supplement Number:
000