Duns Number:079398589
Device Description: SureLOK MIS 3L Navigated Instrument Kit
Catalog Number
70-BK-0108
Brand Name
Navigated Instrument System
Version/Model Number
70-BK-0108
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
K181606
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
c47674a3-5b94-4e97-b05c-cdfbcad6f752
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 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 | 1423 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
| U | Unclassified | 26 |