Catalog Number

-

Brand Name

dpl®

Version/Model Number

FLJOINT

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

e21d9c9d-7b6e-4d8c-a662-fa9346f91e6e

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Package DI Number

B347FLJOINT1

Quantity per Package

5

Contains DI Package

B347FLJOINT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-