Catalog Number

-

Brand Name

Celluma

Version/Model Number

Home

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

-

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

5a35c5b9-ee92-4dc2-8047-b1179a4207a4

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 26, 2017

Package DI Number

00850523007419

Quantity per Package

5

Contains DI Package

00850523007402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-