Catalog Number

-

Brand Name

scalamobil®

Version/Model Number

S35

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

K920105

Product Code

ING

Product Code Name

Elevator, Wheelchair, Portable

Public Device Record Key

f610ee21-bab1-4faa-94ee-2971f52b80a8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-