Catalog Number

238.19

Brand Name

Silvercrest

Version/Model Number

SWKK60A1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

d0a307d6-7bef-4db2-bf8d-6c42f2dc0435

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 31, 2021

Package DI Number

14055334351185

Quantity per Package

4

Contains DI Package

04055334351188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack