Catalog Number

SLT-MR

Brand Name

AED-SLT MIDAS REX-STOP

Version/Model Number

SLT-MR

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

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Public Device Record Key

205f6e53-0b03-4d2e-8ee7-c9cfbe8eceaf

Public Version Date

August 06, 2020

Public Version Number

1

DI Record Publish Date

July 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-