Ride Designs Custom AccuSoft Cushion Extra Outer Incont Cover - Aspen Seating LLC

Duns Number:020311895

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


More Product Details

Catalog Number

-

Brand Name

Ride Designs Custom AccuSoft Cushion Extra Outer Incont Cover

Version/Model Number

AccuSoft Extra Outer Incont Cover

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

2fc00283-4653-4f56-84e2-888a9fcce394

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASPEN SEATING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4