Duns Number:109903521
Device Description: Navio Checkpoint Verification Pins
Catalog Number
PFSD01009
Brand Name
Navio
Version/Model Number
PFSD01009
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
-
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
60120e7a-d2af-4c5e-9a89-c6d2f4a9ea19
Public Version Date
October 16, 2018
Public Version Number
3
DI Record Publish Date
January 22, 2016
Package DI Number
20885556628724
Quantity per Package
4
Contains DI Package
00885556628720
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |