Duns Number:076059836
Device Description: Flexible Fabric Adhesive Bandages, all one size, 2 IN x 4 IN (50 mm x 101 mm)
Catalog Number
-
Brand Name
GoodSense
Version/Model Number
846036001433
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"
Yes
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
ffba3040-e6d6-481d-915b-759af738fdbe
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 2020
Package DI Number
10846036001430
Quantity per Package
24
Contains DI Package
00846036001433
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |