Duns Number:800777117
Device Description: Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.
Catalog Number
B59800
Brand Name
PDI® Electrode Prep Pad
Version/Model Number
B59800
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 04, 2022
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"
-
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
KOY
Product Code Name
Degreaser, Skin, Surgical
Public Device Record Key
92d58e34-9441-429a-831b-26ed858b63d4
Public Version Date
May 04, 2022
Public Version Number
3
DI Record Publish Date
August 03, 2020
Package DI Number
10310819000472
Quantity per Package
100
Contains DI Package
00310819000475
Package Discontinue Date
May 04, 2022
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| U | Unclassified | 1 |