BILIARY DRAINAGE TUBE SET

Basic Information

• Brand Name: BILIARY DRAINAGE TUBE SET
• Primary DI: 04953170045929
• Version / Model: MAJ-348
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 10
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: eba37e77-88a2-4100-874e-f0d35f1c8ecd
• Distribution End Date: 2022-08-12

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65546	Biliary drainage catheter endoscopic pusher	An invasive, flexible, tubular device intended to be used to manually push a biliary drainage catheter through the working channel of an endoscope and into position within the bile duct using a guidewire. The guidewire and catheter are not included with the pusher. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170045929	GS1
Package	14953170045926	GS1		1	Not in Commercial Distribution	2022-08-12

Customer Contacts

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