Duns Number:958758146
Device Description: Preventive Pad - (28" x 16" x 4.5") - Wipe Down
Catalog Number
PPWD281645
Brand Name
Preventive Pad
Version/Model Number
PPWD281645
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
13b0ea65-0525-4ba0-85a1-f933374d086d
Public Version Date
July 30, 2021
Public Version Number
1
DI Record Publish Date
July 22, 2021
Package DI Number
00810006683318
Quantity per Package
10
Contains DI Package
00810006682151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 208 |