Duns Number:039779098
Device Description: A custom engineered set of reusable surgical instruments, housed in a sterilizable storage A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure.
Catalog Number
CIS-003
Brand Name
Instrument Set (Case and Reusable Instruments)
Version/Model Number
CIS-003
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
72b3ae83-d3bd-4187-bc62-1288a25629bc
Public Version Date
July 21, 2022
Public Version Number
2
DI Record Publish Date
June 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |