Catalog Number

-

Brand Name

Rapid Reboot

Version/Model Number

CU-04-100-MED

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

8743d112-33a6-4248-bd00-9432704f8c78

Public Version Date

January 01, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-