AccessGUDID - DEVICE: NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System (00850015518294)

GUDID

Device Identifier (DI) Information

Brand Name: NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Version or Model: Controller/ NaviEC-2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC-US-1002
Company Name: ANX ROBOTICA CORP

Primary DI Number: 00850015518294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024972857 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
65009	Video capsule endoscopy system capsule magnetic manipulation unit	An electrically-powered, noninvasive device designed to control/manoeuvre a video capsule endoscopy system capsule (not included) in the gastrointestinal (GI) tract. It typically consists of a large magnetic device intended to magnetically couple with the capsule (e.g., a robotic arm with a magnet at its distal end, whole-body magnetic bore), patient table, and computer/console with dedicated software and controls; it is not a one-piece, hand-held 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 [?]
K203192	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: ae94ceab-09c4-41f6-b6d4-1dda82fab72e
Public Version Date: January 13, 2023
Public Version Number: 1
DI Record Publish Date: January 05, 2023