CAPSULE ACTIVATOR

Basic Information

• Brand Name: CAPSULE ACTIVATOR
• Primary DI: 04953170214332
• Version / Model: MAJ-1478
• Catalog Number: N2484330
• 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: 8
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: f2c738fc-bb33-4699-b3ed-6ec56474f5f4

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: No
• 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
NEZ	SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE	Gastroenterology, Urology	876.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64391	Video capsule endoscopy system capsule magnetic activator	A non-powered, magnetic component of a video capsule endoscopy system designed to be briefly combined with the system capsule (not included) to activate the capsule’s magnetic switch before the capsule is swallowed by the patient. It is typically cup-shaped for placement and activation of the capsule by its magnetic field. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170214332	GS1

Customer Contacts

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