Catalog Number

-

Brand Name

SEDECAL

Version/Model Number

MILL-EL-B

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IZZ

Product Code Name

Table, Radiographic, Non-Tilting, Powered

Public Device Record Key

e0b44b27-1a06-4781-aaea-e104c46d8993

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-