Catalog Number

355850

Brand Name

Healthy Accents

Version/Model Number

355850

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2019

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

b1c00fca-37d3-4546-8d43-f7b8fb67f303

Public Version Date

November 06, 2019

Public Version Number

4

DI Record Publish Date

May 19, 2017

Package DI Number

10725439992760

Quantity per Package

6

Contains DI Package

00725439992763

Package Discontinue Date

February 21, 2019

Package Status

Not in Commercial Distribution

Package Type

case