Innovex

Basic Information

• Brand Name: Innovex
• Primary DI: 06970034210635
• Version / Model: US31E-12-US
• Company Name: Shanghai AnQing Medical Instrument Co., Ltd
• Labeler DUNS: 544581269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 2
• Public Version Date: 2023-03-13
• Public Version Status: Update
• Public Device Record Key: 479bb8d3-607c-4115-be5d-46af3ecd7679

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
64003	Flexible video ureterorenoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970034210635	GS1