Duns Number:041674552
Device Description: Silk/Cloth Tape 1x2.5 yards
Catalog Number
Not Applicable
Brand Name
MedSource Silk/Cloth Tape
Version/Model Number
NORTH-023141
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
6bae6682-f936-45e1-870c-6821fdc9a212
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 16, 2021
Package DI Number
00840155411395
Quantity per Package
630
Contains DI Package
00816703023457
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 |