Duns Number:111926675
Device Description: Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version 1)
Catalog Number
PH-635-70 + PH-K-1
Brand Name
PHASOR
Version/Model Number
PH-635-70 + PH-K-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 22, 2120
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
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
K161704
Product Code
HBE
Product Code Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Public Device Record Key
712f0f79-a911-48b9-b428-75f45345ed65
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
May 22, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 39 |