AccessGUDID - DEVICE: NaviCam Capsule Endoscope System (00850015518188)

GUDID

Device Identifier (DI) Information

Brand Name: NaviCam Capsule Endoscope System
Version or Model: Recorder/AKR-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC-US-1006
Company Name: ANX ROBOTICA CORP

Primary DI Number: 00850015518188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024972857 *Terms of Use

Device Description: DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel 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 to be controlled by an operator.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
64666	Video capsule endoscopy system monitor	An electrically-powered, portable component of a video capsule endoscopy system designed to be worn by a patient to continuously display and record photographic image data from an ingested video capsule (not included). It typically incorporates a display and controls and may include connection cables. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKZ	Magnetically Maneuvered Capsule Endoscopy System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190037	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb60d6cb-e005-4a50-8300-d1a89f110002
Public Version Date: January 13, 2023
Public Version Number: 2
DI Record Publish Date: December 08, 2020