C-MATT - 1400-SG-3 Sheerguard Series 3 X 6 X 26 Armboard - CASCO MANUFACTURING SOLUTIONS, INC.

Duns Number:004253936

Device Description: 1400-SG-3 Sheerguard Series 3 X 6 X 26 Armboard Pad

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More Product Details

Catalog Number

91470

Brand Name

C-MATT

Version/Model Number

91470

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

FNJ

Product Code Name

BED, MANUAL

Device Record Status

Public Device Record Key

94df5fc1-06f6-41e4-a414-b38818ae752f

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

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