Duns Number:187232066
Device Description: REVERSE PE-INLAY, 36 MM DIA CENTERED, +3 MM
Catalog Number
105-36-03
Brand Name
Ingen SEVIIN® Shoulder System
Version/Model Number
105-36-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120374
Product Code
PHX
Product Code Name
Shoulder Prosthesis, Reverse Configuration
Public Device Record Key
31fc5d8d-00ef-445c-b274-d64f62d5b787
Public Version Date
March 28, 2019
Public Version Number
1
DI Record Publish Date
March 20, 2019
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. | 61 |