Catalog Number

JY6100

Brand Name

ADVOCATE HEATING PAD CLASSIC SIZE

Version/Model Number

327

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

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

b1bfb4a5-0450-40cf-9e13-d2e45cccd134

Public Version Date

July 13, 2020

Public Version Number

3

DI Record Publish Date

March 10, 2017

Package DI Number

20894046001558

Quantity per Package

12

Contains DI Package

00894046001554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

327-C