Duns Number:080506581
Device Description: SIGMA MAKE TO ORDER 2 Degree Varus / Valgus 0 Degree Posterior Slope Reversible Tibia Cutt SIGMA MAKE TO ORDER 2 Degree Varus / Valgus 0 Degree Posterior Slope Reversible Tibia Cutting Block
Catalog Number
299954007
Brand Name
SIGMA
Version/Model Number
2999-54-007
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
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
5fb5b76b-ee05-497a-9d49-7040d41347b4
Public Version Date
May 13, 2022
Public Version Number
2
DI Record Publish Date
April 19, 2018
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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |