Duns Number:004135503
Device Description: Pack of 100 70% Isopropyl Alcohol Prep Pads.
Catalog Number
62379-005-06
Brand Name
Pharmacist Choice
Version/Model Number
Alcohol Prep Pad 100ct
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
b93474d2-2114-4230-a4a6-8d249479e1b9
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
10898302001972
Quantity per Package
50
Contains DI Package
00898302001975
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 19 |