Catalog Number

-

Brand Name

Grafco

Version/Model Number

4507-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

01c38b51-b236-4b24-be79-647dd3c7be6c

Public Version Date

July 02, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M368450712

Quantity per Package

50

Contains DI Package

M368450711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-