Duns Number:132016168
Device Description: Medicopaste Bandage
Catalog Number
-
Brand Name
GRAFCO
Version/Model Number
1565 4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
cc0a5ae6-786b-45f0-88b7-dbfef3ebd41e
Public Version Date
September 16, 2019
Public Version Number
1
DI Record Publish Date
September 06, 2019
Package DI Number
M368156542
Quantity per Package
12
Contains DI Package
M368156541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 202 |