Catalog Number

498011

Brand Name

Anodyne Therapy

Version/Model Number

120-2

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

-

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

K931261

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

93c16211-d20a-4593-97b4-95134fe2b1ca

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

May 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-