PROTECTION TUBE

Basic Information

• Brand Name: PROTECTION TUBE
• Primary DI: 04953170064685
• Version / Model: MD-515
• 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: 6
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 866f4e09-90ae-462a-ab27-115267e6235a

Device Description

PROTECTION TUBE MD-515

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: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65703	Endoscope transport/sterilization protective cover, reusable	A noninvasive device, typically in the form of a flexible tubing, designed to cover the invasive section of an endoscope (e.g., angioscope) to protect it from damage during transport or sterilization/disinfection; it is not intended to be used 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
Primary	04953170064685	GS1

Customer Contacts

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