HOLDER FOR HC-RP

Basic Information

• Brand Name: HOLDER FOR HC-RP
• Primary DI: 04953170305849
• Version / Model: MAJ-1938
• Catalog Number: N3807700
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2023-12-27
• Public Version Status: Update
• Public Device Record Key: aaf95c06-84e0-4f5b-9186-562928ac7a93

Device Description

MAJ-1938 ScopeGuide Holder for HC-RC

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: No
• 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: 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
43266	Sensor holder, reusable	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170305849	GS1
Unit of Use	84953170305845	GS1

Customer Contacts

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