Duns Number:831375089
Device Description: Maternity Pad, 10.5"x4", 16/bg
Catalog Number
3631
Brand Name
PremierPro
Version/Model Number
3631
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
HHD
Product Code Name
Pad, Menstrual, Unscented
Public Device Record Key
c0a125f1-1e79-41d2-bc22-db1d5a05f48e
Public Version Date
June 21, 2022
Public Version Number
2
DI Record Publish Date
August 04, 2020
Package DI Number
10818566017564
Quantity per Package
12
Contains DI Package
00818566017567
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 |