OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE

Basic Information

• Brand Name: OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE
• Primary DI: 04953170068751
• Version / Model: OLYMPUS CHF TYPE BP30
• 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: 6
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 8971040b-8b1d-46ab-b6ab-63e1932621e3
• Distribution End Date: 2024-01-12

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FBN	Choledochoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34939	Flexible fibreoptic choledochoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique), or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170068751	GS1

Customer Contacts

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