Duns Number:078812602
Device Description: MIS ADAPTER DRIVER
Catalog Number
97-39P
Brand Name
DeGen Navigated Instrumentation
Version/Model Number
97-39P
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
K203816
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
ac9f5c02-8cb7-4764-9b94-dfed261e43c4
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
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 | 511 |
2 | A medical device with a moderate to high risk that requires special controls. | 4143 |