Debris Collection Bottle for LUS/LUS-2

Basic Information

• Brand Name: Debris Collection Bottle for LUS/LUS-2
• Primary DI: 04953170138546
• Version / Model: MAJ-1078
• 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: 9
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: cc09c8a3-b260-4dcf-9de6-5caf720d3a1b
• Distribution End Date: 2022-08-09

Device Description

MAJ-1078 DEBRIS BOTTLE FOR LUS -2

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["High-level Disinfectant", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEO	Lithotriptor, ultrasonic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44943	Surgical suction system collection container, reusable	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170138546	GS1

Customer Contacts

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