Action® - Xact® LP2 Cushion 20x16 - ACTION PRODUCTS, INC.

Duns Number:067543058

Device Description: Xact® LP2 Cushion 20x16

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More Product Details

Catalog Number

XP2016

Brand Name

Action®

Version/Model Number

Seating System

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"

Yes

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

-

Product Code Details

Product Code

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

6ff6ae74-bc51-4de8-a7e6-61048d4e5557

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

February 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACTION PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 993
2 A medical device with a moderate to high risk that requires special controls. 49