Duns Number:068586441
Device Description: Bandage Adhesive Fabric 1" x 3" 100/Box
Catalog Number
783811
Brand Name
Dealmed
Version/Model Number
859140003818
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
fbe11699-3042-4472-b63f-61d68e50f5fb
Public Version Date
October 02, 2020
Public Version Number
2
DI Record Publish Date
September 11, 2020
Package DI Number
10859140003818
Quantity per Package
24
Contains DI Package
00859140003811
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 |