Duns Number:009831413
Device Description: PRO ADVANTAGE COVER SHOE NON-CONDUCTIVE BLUE 100/BX
Catalog Number
P702010
Brand Name
PRO ADVANTAGE
Version/Model Number
P702010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
FXP
Product Code Name
Cover, Shoe, Operating-Room
Public Device Record Key
27d1207d-8893-4dc1-b38d-ddc9c1349292
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 09, 2019
Package DI Number
M220P7020105
Quantity per Package
300
Contains DI Package
M220P7020103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |