MiroCam Capsule Endoscope System

GUDID 08809260260320

IntroMedic Co., LTD.

Video capsule endoscopy system capsule
Primary Device ID08809260260320
NIH Device Record Key696c1946-d555-45a1-9ccd-73b3c054b8f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroCam Capsule Endoscope System
Version Model NumberMC1600-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
GS108809260260122 [Unit of Use]
GS108809260260320 [Primary]
GS118809260260327 [Package]
Package: Large Box [20 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 Number2
Public Version Date2020-02-06
Device Publish Date2019-06-17

On-Brand Devices [MiroCam Capsule Endoscope System]

08809260260498Package system(MC1600-B Capsule and MR2000 Receiver)
08809260260320MC1600-B
98809260260446Package system(MC1200-B capsule, MR2000 receiver)
08809260260290MC1200-B
08809260260269MC1000-B
08809260260191MR2000
18809260260587MC1600-B
18809260260570MC2000-B
18809260260563MC1200-B

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