Catalog Number

-

Brand Name

reVive®

Version/Model Number

RVLBAA

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

cf361d53-c97a-4006-a658-334587ec0ad8

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

December 05, 2017

Package DI Number

B347RVLBAA1

Quantity per Package

10

Contains DI Package

B347RVLBAA0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-