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
751041BBG
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
990e51ca-2923-4d21-9e0c-04c03031bd7c
Public Version Date
October 20, 2022
Public Version Number
4
DI Record Publish Date
December 14, 2018
Package DI Number
20887761000531
Quantity per Package
4
Contains DI Package
00887761019744
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 |