Catalog Number

-

Brand Name

NA

Version/Model Number

FGS-0193-J

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NEZ

Product Code Name

SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Public Device Record Key

6f577691-caa6-4d1f-a9f2-94d72de71706

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-