WiScope®

Basic Information

• Brand Name: WiScope®
• Primary DI: 00850023925176
• Version / Model: OTU-C300R
• Company Name: Otu Medical Inc.
• Labeler DUNS: 100796993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-18
• Public Version: 2
• Public Version Date: 2023-03-27
• Public Version Status: Update
• Public Device Record Key: 3c2c9ebb-55f0-4a94-8136-a46cf7a2f19a

Device Description

Single-Use Digital Flexible Cystoscope

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850023925173	GS1		2	In Commercial Distribution
Primary	00850023925176	GS1
Package	20850023925170	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K212202	000