Duns Number:792932626
Catalog Number
-
Brand Name
Stapix Superelastic Nitinol Staple System
Version/Model Number
SK201818
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 19, 2019
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
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
3c7be937-b8d7-4958-9a8c-aaa4c836a479
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
October 17, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 192 |