Duns Number:961027315
Device Description: SKIN CLOSURE STRIP STERILE FILAMENT REINFORCED CURL-RESISTANT BREATHABLE 0.25IN X 1.5IN
Catalog Number
S1042
Brand Name
CARDINAL HEALTH
Version/Model Number
S1042
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K874813,K874813,K874813,K874813
Product Code
FPX
Product Code Name
Strip, adhesive, closure, skin
Public Device Record Key
60c4a9c2-4190-4f1d-9607-9eed93b9b8a8
Public Version Date
July 03, 2019
Public Version Number
1
DI Record Publish Date
June 25, 2019
Package DI Number
20885380027878
Quantity per Package
50
Contains DI Package
00885380027874
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |