Duns Number:068586441
Device Description: Bandage Adhesive Fabric 3/4" x 3" 100/Box
Catalog Number
783810
Brand Name
Dealmed
Version/Model Number
859140003801
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)
-
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
9c64ab33-0b25-41fc-bb3e-5cb1d93be686
Public Version Date
October 09, 2020
Public Version Number
2
DI Record Publish Date
September 14, 2020
Package DI Number
10859140003801
Quantity per Package
24
Contains DI Package
00859140003804
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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |