Catalog Number

-

Brand Name

Hammacher Schlemmer‎

Version/Model Number

F301SP

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

992e3d9f-609f-4334-8f52-f3d71ff2f71d

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

B347F301SP1

Quantity per Package

8

Contains DI Package

B347F301SP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-