Duns Number:592616445
Device Description: A reusable manual surgical instrument intended to be used during an orthopaedic surgical p A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
Catalog Number
4240-4070
Brand Name
Classic Patella Clamp - Medacta
Version/Model Number
4240-4070
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
-
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
HXD
Product Code Name
Clamp
Public Device Record Key
b0c49630-d615-40bc-b3cd-e1c2326d1a46
Public Version Date
June 14, 2022
Public Version Number
1
DI Record Publish Date
June 06, 2022
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 | 107 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |