Wheelchair Cushion - Foam Wheelchair Cushion (18" x 18" x 4") - PRIMO INC

Duns Number:958758146

Device Description: Foam Wheelchair Cushion (18" x 18" x 4")

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More Product Details

Catalog Number

WCC18184

Brand Name

Wheelchair Cushion

Version/Model Number

WCC18184

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

Yes

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

f7317b13-a8a8-4dee-a7aa-b93d704f3e10

Public Version Date

July 27, 2021

Public Version Number

3

DI Record Publish Date

February 20, 2019

Additional Identifiers

Package DI Number

00810006683455

Quantity per Package

18

Contains DI Package

00810006682458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each

"PRIMO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208