Catalog Number

-

Brand Name

CAPSULE ACTIVATOR

Version/Model Number

MAJ-1478

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063259,K163069

Product Code

NEZ

Product Code Name

SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Public Device Record Key

f2c738fc-bb33-4699-b3ed-6ec56474f5f4

Public Version Date

November 17, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-