Gynex

Basic Information

• Brand Name: Gynex
• Primary DI: 00850003294841
• Version / Model: GYN SE8200
• Company Name: JOSNOE MEDICAL, INC.
• Labeler DUNS: 965627859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-08
• Public Version: 1
• Public Version Date: 2024-11-18
• Public Version Status: New
• Public Device Record Key: 8b7bd6c0-b2c0-4ced-8624-9e1ce43d3009

Device Description

Insufflation Set Smoke Evacutor

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850003294834	GS1	Inner Box	4	In Commercial Distribution
Primary	00850003294841	GS1
Package	00850003294827	GS1	Individual	12	In Commercial Distribution