Duns Number:109903521
Device Description: NAVIO HANDPIECE THUMBERSCREW
Catalog Number
PFSR100026
Brand Name
NAVIO
Version/Model Number
PFSR100026
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
K160537,K160537
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
058cfc84-ace7-4825-a680-f887ffbca766
Public Version Date
November 09, 2018
Public Version Number
1
DI Record Publish Date
October 09, 2018
Package DI Number
20885556648425
Quantity per Package
2
Contains DI Package
00885556648421
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 |