OLYMPUS

Basic Information

• Brand Name: OLYMPUS
• Primary DI: 04953170420283
• Version / Model: BML-610A
• 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: 2019-12-10
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6370116b-2ea3-472a-8ff5-3dc413c545ba
• Distribution End Date: 2022-04-22

Device Description

Single Use Mechanical Lithotriptor BML-610A

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: No
• 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
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	876.4500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64360	Manual biliary stone fragmenter handle, noninvasive, reusable	A noninvasive, manual device intended to be connected to a manual biliary stone fragmenter (not included) and used to create adequate torque (power) to crush a biliary stone once it has been grasped by the distal mechanism of the fragmenter during an endoscopic procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170420280	GS1		1	Not in Commercial Distribution	2022-04-22
Primary	04953170420283	GS1

Customer Contacts

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