NaviCam Stomach System

Basic Information

• Brand Name: NaviCam Stomach System
• Primary DI: 00850015518072
• Version / Model: Locator AKS-1
• Catalog Number: SB-US-2006
• Company Name: ANX ROBOTICA CORP
• Labeler DUNS: 024972857
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-08
• Public Version: 3
• Public Version Date: 2023-01-13
• Public Version Status: Update
• Public Device Record Key: 685391fa-df2b-41dd-9bbc-25ca31c752f3

Device Description

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.

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: Yes
• Has Lot/Batch Number: No
• 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
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	876.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64665	Video capsule endoscopy monitoring kit	A collection of noninvasive devices intended to assist with the monitoring of image data from an ingested video capsule (not included), as it passes through the gastrointestinal (GI) tract. It typically consists of a monitor, an antenna that receives the wireless signals from the capsule, and additional devices utilized for the recording procedure (e.g., connection cables, holders, protectors); it may in addition include a capsule activator(s). This is a reusable device.	No	Active
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	00850015518072	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN190037	000