Duns Number:080935429
Device Description: Alcohol Prep,2 Ply, Medium
Catalog Number
6818
Brand Name
Webcol
Version/Model Number
6818
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
7832094a-4213-4d24-a173-e6480fbaa57b
Public Version Date
June 10, 2021
Public Version Number
8
DI Record Publish Date
June 27, 2018
Package DI Number
30884527020649
Quantity per Package
4000
Contains DI Package
20884527020642
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |