MiroCam Capusle Endoscope System

GUDID 18809260260358

IntroMedic Co., LTD.

Video capsule endoscopy system capsule
Primary Device ID18809260260358
NIH Device Record Key3946c1d4-edda-409c-a404-7f1b5cf28b59
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroCam Capusle Endoscope System
Version Model NumberMC2000-B
Company DUNS631065794
Company NameIntroMedic Co., LTD.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809260260153 [Unit of Use]
GS108809260260351 [Primary]
GS118809260260358 [Package]
Contains: 08809260260351
Package: Large box [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2020-02-06
Device Publish Date2018-02-12

On-Brand Devices [MiroCam Capusle Endoscope System]

08809260260436Package System(MC2000-B Capsule and MR2000 Receiver)
18809260260358MC2000-B

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