Duns Number:305682023
Device Description: 2121M Skin Prep Pads - Abrasive pads Packing: 30 pouch/ 500 inner box/ 1500 carton
Catalog Number
2121M
Brand Name
Skin Prep PadAbrasive Pad for Skin Preparation
Version/Model Number
2121M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 06, 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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
6fd74e5f-f69d-4d72-bbac-d61848f8da75
Public Version Date
February 07, 2022
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
05060038515292
Quantity per Package
3
Contains DI Package
05060038515285
Package Discontinue Date
February 06, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |