WiScope®

Basic Information

• Brand Name: WiScope®
• Primary DI: 00850023925305
• Version / Model: OTU-OM100R
• Company Name: Otu Medical Inc.
• Labeler DUNS: 100796993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-30
• Public Version: 1
• Public Version Date: 2023-05-08
• Public Version Status: New
• Public Device Record Key: b0c15b27-7a8a-47fe-8a47-1795e96a2229

Device Description

Single-Use Digital Flexible Ureteroscope/Choledochoscope

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
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64074	Flexible video ureteroscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.	No	Active
64055	Flexible video choledochoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. It is typically introduced via a flexible duodenoscope and anatomical images are transmitted to a monitor for viewing typically through a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850023925302	GS1		10	In Commercial Distribution
Primary	00850023925305	GS1