Catalog Number

-

Brand Name

MiroCam Capsule Endoscope System

Version/Model Number

MC1200-B, MR1100

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143663,K143663

Product Code

NEZ

Product Code Name

System, Imaging, Gastrointestinal, Wireless, Capsule

Public Device Record Key

3be1d3a0-501f-4486-a5e6-ba4b653b3d52

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2017

Package DI Number

98809260260385

Quantity per Package

1

Contains DI Package

08809260260382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Large Box