Duns Number:157565946
Catalog Number
320-10-46
Brand Name
Equinoxe
Version/Model Number
320-10-46
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"
-
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
K193098
Product Code
KWS
Product Code Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Public Device Record Key
c1aff489-79ab-437a-92fe-9ff51f5a5aea
Public Version Date
September 21, 2020
Public Version Number
1
DI Record Publish Date
September 13, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3717 |
2 | A medical device with a moderate to high risk that requires special controls. | 7206 |
3 | A medical device with high risk that requires premarket approval | 28 |