Catalog Number

-

Brand Name

Advocate Prep Pads

Version/Model Number

314

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

LKB

Product Code Name

Pad, Alcohol, Device Disinfectant

Public Device Record Key

21e28447-ebd8-4508-898d-c094f662c83f

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

10894046001384

Quantity per Package

100

Contains DI Package

00894046001387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

314-C