Catalog Number

2668

Brand Name

CapsoAccess

Version/Model Number

3

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

K161773,K183192,K192662

Product Code

NEZ

Product Code Name

System, Imaging, Gastrointestinal, Wireless, Capsule

Public Device Record Key

41395993-fdb6-43d4-9185-27e34b346d2e

Public Version Date

December 10, 2020

Public Version Number

9

DI Record Publish Date

July 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-