Duns Number:027680821
Device Description: Intended for skin closure and closure support for sutures and staples
Catalog Number
-
Brand Name
Sterion® Skin Closure
Version/Model Number
751046PBX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
FPX
Product Code Name
Strip, adhesive, closure, skin
Public Device Record Key
125209db-eaad-44ba-979a-0640d2b51659
Public Version Date
October 20, 2022
Public Version Number
4
DI Record Publish Date
May 21, 2019
Package DI Number
10887761000664
Quantity per Package
50
Contains DI Package
00887761000667
Package Discontinue Date
July 07, 2022
Package Status
Not 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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |