Catalog Number

-

Brand Name

PillCam

Version/Model Number

RFB-0590

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

K123864

Product Code

NEZ

Product Code Name

SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Public Device Record Key

cc205f9c-9600-498e-8d91-f0b76a7a5442

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

June 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-