Catalog Number

2795

Brand Name

CapsoCam Plus

Version/Model Number

SV-3

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

K161773,K183192,K192662

Product Code

NEZ

Product Code Name

System, Imaging, Gastrointestinal, Wireless, Capsule

Public Device Record Key

b98684c8-c496-465b-86c9-e168d04410e2

Public Version Date

December 10, 2020

Public Version Number

6

DI Record Publish Date

July 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-