Quickie® Series Manual Wheelchair - Quickie IRIS Manual Wheelchair - SUNRISE MEDICAL (US) LLC

Duns Number:962525056

Device Description: Quickie IRIS Manual Wheelchair

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More Product Details

Catalog Number

ElZ4-2

Brand Name

Quickie® Series Manual Wheelchair

Version/Model Number

ElZ4-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2021

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"

Yes

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

-

Product Code Details

Product Code

IOR

Product Code Name

WHEELCHAIR, MECHANICAL

Device Record Status

Public Device Record Key

6fe47976-b25d-4756-ba0e-638fe9b29003

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNRISE MEDICAL (US) LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 18