CMATT - WHEELCHAIR REPLACEMENT COVER 18 X16 - CASCO MANUFACTURING SOLUTIONS, INC.

Duns Number:004253936

Device Description: WHEELCHAIR REPLACEMENT COVER 18 X16

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More Product Details

Catalog Number

H12681

Brand Name

CMATT

Version/Model Number

H12681

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

844e66e7-2b84-464b-92f5-10ebe5a18493

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CASCO MANUFACTURING SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 849
2 A medical device with a moderate to high risk that requires special controls. 1