NaviCam Small Bowel Capsule Endoscopy System SB-US-2006

GUDID 06921010800531

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.

ANKON Technologies Co.,Ltd.

Video capsule endoscopy monitoring kit
Primary Device ID06921010800531
NIH Device Record Keyd1ae7db8-98c8-4608-82a4-d26054c8405b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviCam Small Bowel Capsule Endoscopy System
Version Model NumberLocator/AKS-1
Catalog NumberSB-US-2006
Company DUNS549329633
Company NameANKON Technologies Co.,Ltd.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn
Phone+8613397176599
Emailsifeng.wang@ankoninc.com.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106921010800531 [Primary]

FDA Product Code

NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-01-01
Device Publish Date2022-12-27

On-Brand Devices [ NaviCam Small Bowel Capsule Endoscopy System]

06921010800531The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. I
06921010800524It is used for receiving image data wirelessly transmitted from the Capsule.
06921010800517The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium bat
16921010800507The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract
16921010800491The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract

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