Catalog Number

-

Brand Name

Emprint HP

Version/Model Number

CARTHP

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

K200796

Product Code

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

b06dc6c7-9ec4-4db2-be15-ecda788a2ccb

Public Version Date

May 20, 2022

Public Version Number

2

DI Record Publish Date

November 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-