REFERENCE PLATE COVER

Basic Information

• Brand Name: REFERENCE PLATE COVER
• Primary DI: 04953170305719
• Version / Model: MAJ-1880
• Catalog Number: N3806500
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 8
• Public Version Date: 2023-12-26
• Public Version Status: Update
• Public Device Record Key: 729b1754-764c-4878-a451-adb9d1ae6e5e

Device Description

REFERENCE PLATE COVER

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDF	Colonoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
FDA	Enteroscope And Accessories	Gastroenterology, Urology	876.1500	2
PGU	Spatial Imaging For Display Of Endoscope Position	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62743	Sensor holder, single-use	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170305719	GS1
Unit of Use	84953170305715	GS1

Customer Contacts

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