Duns Number:046189866
Catalog Number
73-2712
Brand Name
STERNALOCK® BLU SYSTEM
Version/Model Number
73-2712
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2020
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
K110574,K121302,K161896
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
b8bf211c-b280-4dc4-9403-2ee467cc16af
Public Version Date
July 27, 2020
Public Version Number
4
DI Record Publish Date
October 11, 2015
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 | 1783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11874 |
| 3 | A medical device with high risk that requires premarket approval | 34 |