Duns Number:927083808
Device Description: CANNULATED TAP, 7.5MM, PHOENIX NAVIGATED BL
Catalog Number
-
Brand Name
NAVIGATED INSTRUMENTS;PHOENIX SFS
Version/Model Number
20-1227
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"
Yes
For Single-Use
Yes
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
498c4efd-569a-4b0c-9c3b-01f611b9ef55
Public Version Date
February 11, 2020
Public Version Number
1
DI Record Publish Date
February 03, 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 | 2497 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5891 |
| 3 | A medical device with high risk that requires premarket approval | 104 |