Catalog Number

-

Brand Name

MiroCam Capsule Endoscope System

Version/Model Number

MC1600-B, 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

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

K180732,K180732

Product Code

NEZ

Product Code Name

System, Imaging, Gastrointestinal, Wireless, Capsule

Public Device Record Key

4fb47def-9130-4817-a7ea-d46cd481d6a8

Public Version Date

August 07, 2020

Public Version Number

3

DI Record Publish Date

June 17, 2019

Package DI Number

98809260260491

Quantity per Package

1

Contains DI Package

08809260260498

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Large Box