Catalog Number

-

Brand Name

ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET

Version/Model Number

MAJ-2027

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123421,K163069,K173459,K123421,K163069,K173459

Product Code

NEZ

Product Code Name

SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Public Device Record Key

17ddc796-982d-486e-872b-27d8f4b35fd7

Public Version Date

December 15, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-