Savaria - Savaria Concord Lifts Inc

Duns Number:245449095

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More Product Details

Catalog Number

-

Brand Name

Savaria

Version/Model Number

Stairfriend

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023852

Product Code Details

Product Code

ILK

Product Code Name

Transport, Patient, Powered

Device Record Status

Public Device Record Key

5018107b-7c53-41a0-b8fc-e15850f98fe1

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

September 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAVARIA CONCORD LIFTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 59
2 A medical device with a moderate to high risk that requires special controls. 12