Duns Number:041674552
Device Description: PVP Medium Prep Pad
Catalog Number
Not Applicable
Brand Name
MedSource Antiseptic Towelettes
Version/Model Number
MS-17502
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRJ
Product Code Name
Disinfectant, Medical Devices
Public Device Record Key
a34a7c01-97ed-407c-9eeb-90d26a016b84
Public Version Date
May 21, 2021
Public Version Number
1
DI Record Publish Date
May 13, 2021
Package DI Number
00816703025666
Quantity per Package
10
Contains DI Package
00816703025659
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |