NaviCam Stomach System

GUDID 00850015518072

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

ANX ROBOTICA CORP

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Primary Device ID00850015518072
NIH Device Record Key685391fa-df2b-41dd-9bbc-25ca31c752f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviCam Stomach System
Version Model NumberLocator AKS-1
Company DUNS024972857
Company NameANX ROBOTICA CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015518072 [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 Date2020-12-16
Device Publish Date2020-12-08

Devices Manufactured by ANX ROBOTICA CORP

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00850015518072 - NaviCam Stomach System2020-12-16NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.
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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
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