Duns Number:831375089
Device Description: Protective Underwear, Ultra, Heavy, X-Large, 4 Blue strands, 14/bg
Catalog Number
7622
Brand Name
PremierPro
Version/Model Number
7622
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
c8740dd7-41a4-46c3-a852-7b9737e42252
Public Version Date
September 11, 2020
Public Version Number
1
DI Record Publish Date
September 03, 2020
Package DI Number
10811220033184
Quantity per Package
4
Contains DI Package
00811220033187
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 |