Duns Number:004253936
Device Description: CASCO CART COVER, 63H X 48L X 18W (01-DAF NYLON, 02-GREY BRUIN, 03-BLUE BRUIN)
Catalog Number
H12661
Brand Name
CASCO
Version/Model Number
H12661
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FMW
Product Code Name
Cover, Mattress (Medical Purposes)
Public Device Record Key
53d541ac-7e8b-4f73-86d2-f19a9bf875a6
Public Version Date
August 16, 2021
Public Version Number
1
DI Record Publish Date
August 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |