Catalog Number

-

Brand Name

Hammacher Schlemmer

Version/Model Number

HSANKLE

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

4943829e-cdc5-4fbe-9add-21e0ea48c80c

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

March 19, 2018

Package DI Number

B347HSANKLE1

Quantity per Package

20

Contains DI Package

B347HSANKLE0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-