Duns Number:080935429
Device Description: Alcohol Prep,2 Ply, Medium
Catalog Number
63001
Brand Name
Webcol
Version/Model Number
63001
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
2aa5e137-ebfa-4807-b189-281a0567b6f8
Public Version Date
December 06, 2021
Public Version Number
6
DI Record Publish Date
June 30, 2018
Package DI Number
00884527020679
Quantity per Package
200
Contains DI Package
10884527020676
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
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 |