Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302529-200-0000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2022

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"

Yes

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

K903300

Product Code

-

Product Code Name

-

Public Device Record Key

7c736c52-26a7-4515-aec6-4336e94c73cf

Public Version Date

September 26, 2022

Public Version Number

3

DI Record Publish Date

December 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-