NaviCam Small Bowel Capsule Endoscopy System CP-US-7005, CP-US-7006

GUDID 16921010800491

The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract.

ANKON Technologies Co.,Ltd.

Video capsule endoscopy system capsule
Primary Device ID16921010800491
NIH Device Record Keyf086d5f3-b0c7-4d37-838b-c5448c1982c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviCam Small Bowel Capsule Endoscopy System
Version Model NumberCapsule/AKES-11SW
Catalog NumberCP-US-7005, CP-US-7006
Company DUNS549329633
Company NameANKON Technologies Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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
GS106921010800494 [Primary]
GS116921010800491 [Package]
Contains: 06921010800494
Package: box [10 Units]
In Commercial Distribution

FDA Product Code

NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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