Catalog Number

-

Brand Name

CERAGEM Master V6

Version/Model Number

CGM MB-1701

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

K220572

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

f4572ab1-71c5-4bf1-92a9-3d06548ea2bd

Public Version Date

July 01, 2022

Public Version Number

4

DI Record Publish Date

March 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-