Duns Number:004253936
Device Description: CMATT COMFORT ULTIMA W/ POLYCARBONATE URETHANE COVER, COMPLETELY SEALED, 6 X 36 X 80, CAL CMATT COMFORT ULTIMA W/ POLYCARBONATE URETHANE COVER, COMPLETELY SEALED, 6 X 36 X 80, CAL 129 FED1633
Catalog Number
H12136-P
Brand Name
CMATT
Version/Model Number
H12136-P
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
9fa4d30f-b6d6-4593-a203-f3c2e5cb2d83
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
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 |