Duns Number:041674552
Device Description: Cloth Tape-Porous 1" x 10 yards
Catalog Number
Not Applicable
Brand Name
MedSource Tape
Version/Model Number
MS-15510
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)
-
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
eebb8d88-b205-4a21-b379-4e3cef3630fd
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
00816703025109
Quantity per Package
12
Contains DI Package
00816703025093
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 | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |