Duns Number:958758146
Device Description: Preventive Pad - Standard (28" x 16" x 4.5") - Sheepskin
Catalog Number
PPSS281645
Brand Name
Preventive Pad
Version/Model Number
PPWD281645
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2021
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
bc2b805d-733e-4071-854d-602b32f4ea7d
Public Version Date
July 23, 2021
Public Version Number
3
DI Record Publish Date
February 20, 2019
Package DI Number
00810006680973
Quantity per Package
10
Contains DI Package
00810006680584
Package Discontinue Date
January 01, 2021
Package Status
Not 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 |