DynaRide S 3 Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR - DYNAREX CORPORATION

Duns Number:008124539

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

DynaRide S 3 Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR

Version/Model Number

10230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K070176

Product Code Details

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

faa66a66-262c-4a43-9b99-d7b282011db3

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2