Duns Number:783518983
Device Description: • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pad • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pads per box• For external use only
Catalog Number
-
Brand Name
Pure Comfort Alcohol Pads
Version/Model Number
PureAlc
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LKB
Product Code Name
Pad, Alcohol, Device Disinfectant
Public Device Record Key
ac486932-8a35-4452-9456-f92034a99ec9
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
February 26, 2020
Package DI Number
10860003125509
Quantity per Package
100
Contains DI Package
00860003125502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |