Catalog Number

2239

Brand Name

Curity

Version/Model Number

2239

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

Yes

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

ITG

Product Code Name

BANDAGE, CAST

Public Device Record Key

f8fbcd6c-0fa9-4021-821c-0278fa09bf53

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

June 22, 2018

Package DI Number

20884527015372

Quantity per Package

96

Contains DI Package

10884527015375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE