Duns Number:139105691
Device Description: T27 Non-Cannulated Shaft, SI-LOK Select Driver, GI1
Catalog Number
-
Brand Name
SI-LOK
Version/Model Number
6202.6651
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
K183119
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
35f845d3-f6f3-4f00-bbec-baa7f123ffb6
Public Version Date
March 16, 2020
Public Version Number
1
DI Record Publish Date
March 08, 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 | 4975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34645 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 232 |