Duns Number:831375089
Device Description: Underpad, Maximum Absorbency, 30" x 36", Blue, 5/bg
Catalog Number
676111
Brand Name
PremierPro
Version/Model Number
676111
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"
Yes
For Single-Use
Yes
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
FRL
Product Code Name
Fiber, Medical, Absorbent
Public Device Record Key
fb7fa176-e237-4bbc-b783-a55cbfcd501a
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 03, 2020
Package DI Number
10811220032477
Quantity per Package
8
Contains DI Package
00811220032470
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |