Catalog Number

-

Brand Name

MiroCam Capsule Endoscope System

Version/Model Number

MR2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170438,K170438

Product Code

NEZ

Product Code Name

System, Imaging, Gastrointestinal, Wireless, Capsule

Public Device Record Key

39069d52-f101-4816-b7cd-615636d204d3

Public Version Date

August 07, 2020

Public Version Number

6

DI Record Publish Date

February 12, 2018

Package DI Number

18809260260198

Quantity per Package

3

Contains DI Package

08809260260191

Package Discontinue Date

February 12, 2018

Package Status

Not in Commercial Distribution

Package Type

Large bos