Duns Number:068586441
Device Description: Bandage Adhesive Sheer Spot 7/8", 100/Bx
Catalog Number
783804
Brand Name
Dealmed
Version/Model Number
783804
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2021
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
4c2abb30-5f4d-4e3e-9b7c-959a399bf325
Public Version Date
December 03, 2021
Public Version Number
3
DI Record Publish Date
December 04, 2020
Package DI Number
10859140003795
Quantity per Package
48
Contains DI Package
00859140003798
Package Discontinue Date
December 02, 2021
Package Status
Not 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 |