AccessGUDID - DEVICE: NaviCam Small Bowel Capsule Endoscopy System (06921010800531)

GUDID

Device Identifier (DI) Information

Brand Name: NaviCam Small Bowel Capsule Endoscopy System
Version or Model: Locator/AKS-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB-US-2006
Company Name: ANKON Technologies Co.,Ltd.

Primary DI Number: 06921010800531
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 549329633 *Terms of Use

Device Description: The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position.

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

FDA Product Code

[?]

Product Code	Product Code Name
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: d1ae7db8-98c8-4608-82a4-d26054c8405b
Public Version Date: January 01, 2024
Public Version Number: 2
DI Record Publish Date: December 27, 2022