Duns Number:985523874
Device Description: Porous Tape (2in x 11yd)
Catalog Number
-
Brand Name
AmerisourceBergen
Version/Model Number
10281
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"
-
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
1e41de82-a0fa-4f17-be84-b63282e0227f
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
60368001102812
Quantity per Package
12
Contains DI Package
00368001102810
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |