SonoScape

Basic Information

• Brand Name: SonoScape
• Primary DI: 06945868603434
• Version / Model: EG-550L
• Company Name: SONOSCAPE MEDICAL CORP.
• Labeler DUNS: 545342185
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-07
• Public Version: 1
• Public Version Date: 2022-04-15
• Public Version Status: New
• Public Device Record Key: ee7a6fd9-4ee9-49d3-aed1-c096dedceb25

Device Description

EG-550L Video Gastroscope

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["High-level Disinfectant", "Liquid Chemical"]

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
17663	Flexible video gastroscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945868603434	GS1

Premarket Submissions

Submission Number	Supplement Number
K211882	000