Duns Number:831375089
Device Description: Adult Briefs, Ultra Quilted, Heavy Absorbency, X-Large, Beige, 15/bg
Catalog Number
6633PP
Brand Name
PremierPro
Version/Model Number
6633PP
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
EYQ
Product Code Name
Garment, Protective, For Incontinence
Public Device Record Key
5f4058d5-d178-4acf-86a7-201e5a930adc
Public Version Date
September 21, 2020
Public Version Number
1
DI Record Publish Date
September 11, 2020
Package DI Number
10818566018158
Quantity per Package
4
Contains DI Package
00818566018151
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 |