Duns Number:004253936
Device Description: STRETCHER MATTRESS, 4 X 31 X 76, 2TC, POLYCARBONATE, BIG WHEEL, HOOK / LOOP PATTERN, 2" HO STRETCHER MATTRESS, 4 X 31 X 76, 2TC, POLYCARBONATE, BIG WHEEL, HOOK / LOOP PATTERN, 2" HOOK SEWN TO MATTRESS, 2" LOOP PSA
Catalog Number
H12478-P
Brand Name
CMATT
Version/Model Number
H12478-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
FPP
Product Code Name
Stretcher, Hand-Carried
Public Device Record Key
851b9a87-0b81-45e2-856a-88d9c21a5eba
Public Version Date
January 22, 2020
Public Version Number
1
DI Record Publish Date
January 14, 2020
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 |