Catalog Number

-

Brand Name

CareALL

Version/Model Number

DA85

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KOO

Product Code Name

Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

Public Device Record Key

b6e35186-7421-4397-a608-015f07e3c7e1

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Package DI Number

00085317005788

Quantity per Package

24

Contains DI Package

00085317005795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box