Catalog Number

-

Brand Name

Emprint

Version/Model Number

CAMPA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2020

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

K142048

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

9cf310cb-b976-4760-a932-ec95312302c7

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-