Rapid Reboot - Boot attachment, short - RAPID REBOOT RECOVERY PRODUCTS LLC

Duns Number:080628101

Device Description: Boot attachment, short

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More Product Details

Catalog Number

-

Brand Name

Rapid Reboot

Version/Model Number

BT-01-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

7befe572-9470-439c-b42e-35eb0baaea2c

Public Version Date

December 21, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAPID REBOOT RECOVERY PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33