WHEELCHAIR CUSHION FOAM - 20x16x3 - WHEELCHAIR CUSHION FOAM - 20x16x3 - COMPASS HEALTH BRANDS CORP.

Duns Number:827221698

Device Description: WHEELCHAIR CUSHION FOAM - 20x16x3

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More Product Details

Catalog Number

-

Brand Name

WHEELCHAIR CUSHION FOAM - 20x16x3

Version/Model Number

WCF-203

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

64e034a5-b563-45bc-8d7c-e4bf48421263

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

December 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPASS HEALTH BRANDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 273
U Unclassified 2