NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System MC-US-1002

GUDID 00850015518294

Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator

ANX ROBOTICA CORP

Video capsule endoscopy system capsule magnetic manipulation unit
Primary Device ID00850015518294
NIH Device Record Keyae94ceab-09c4-41f6-b6d4-1dda82fab72e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Version Model NumberController/ NaviEC-2000
Catalog NumberMC-US-1002
Company DUNS024972857
Company NameANX ROBOTICA CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-480-2911
Emailtim.thomas@anxrobotics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015518294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKZMagnetically Maneuvered Capsule Endoscopy System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-13
Device Publish Date2023-01-05

Devices Manufactured by ANX ROBOTICA CORP

00850015518287 - NaviCam Tether2023-01-13 Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the Nav
00850015518294 - NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System2023-01-13Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
00850015518294 - NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System2023-01-13 Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. I
00850015518072 - NaviCam Stomach System2020-12-16 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.
00850015518188 - NaviCam Capsule Endoscope System2020-12-16 DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a n
00850015518195 - NaviCam Capsule Endoscope System2020-12-16 The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic
00850015518201 - NaviCam Capsule Endoscope System2020-12-16 Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a nove
00850015518232 - IntraMarX 3D2020-12-16
00850015518126 - IntraMarX2020-07-16 The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypo
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