Duns Number:039612668
Catalog Number
S-18572
Brand Name
1x3" Plastic Bandage
Version/Model Number
S-18572
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
fe589894-6946-4b8b-85a9-c411ed744f5a
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 21, 2019
Package DI Number
30851253007473
Quantity per Package
54
Contains DI Package
10851253007479
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 2 |