Duns Number:023904428
Device Description: Skin Closure Strips REINFORCED STERILE 1/8” x 3”
Catalog Number
-
Brand Name
McKesson
Version/Model Number
3006
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"
Yes
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
9cd8579e-50ce-4e74-a1d1-ab992bbf3362
Public Version Date
July 28, 2020
Public Version Number
1
DI Record Publish Date
July 20, 2020
Package DI Number
20612479192342
Quantity per Package
50
Contains DI Package
10612479192338
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |