Single Use Stent Insertion Kit V

Basic Information

• Brand Name: Single Use Stent Insertion Kit V
• Primary DI: 04953170347412
• Version / Model: MAJ-1821
• Catalog Number: N4535830
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: 5090a6ef-f8a2-40c0-b4a2-9792dd4aa9c1

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
QGE	Biliary Stent, Drain, And Dilator Accessories	Gastroenterology, Urology	876.5012	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46689	Endoscopic stent-placement system	An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170347419	GS1		1	In Commercial Distribution
Primary	04953170347412	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]