Catalog Number

-

Brand Name

CERAGEM Master V3

Version/Model Number

CGM MB-1101

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

K140592

Product Code

JFB

Product Code Name

Table, Physical Therapy, Multi Function

Public Device Record Key

9cd89808-8d3c-47c2-a98e-b4fd261d0144

Public Version Date

September 13, 2021

Public Version Number

6

DI Record Publish Date

July 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-