Catalog Number

100581-000

Brand Name

BREG

Version/Model Number

100581-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 2019

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

Yes

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

K183702

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

56545d3a-6d95-4fdf-b9d4-6529dc8383a2

Public Version Date

July 17, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-