Duns Number:124763728
Device Description: The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks,
Catalog Number
-
Brand Name
Stern EX Surgical Kit Complete
Version/Model Number
905129
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2021
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
K111798
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
ad4cf0c4-e69e-495d-a6a1-0f565dc3a755
Public Version Date
August 10, 2021
Public Version Number
2
DI Record Publish Date
June 01, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |