Duns Number:044606982
Device Description: Harmonic Focus Long Curved Shears Torque Wrench and Grip Assist for use with Blue Hand Pie Harmonic Focus Long Curved Shears Torque Wrench and Grip Assist for use with Blue Hand Piece Only
Catalog Number
FCS17
Brand Name
Harmonic Focus
Version/Model Number
FCS17
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
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
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
1f8307fa-9cff-4973-ac23-5cb5b42b1622
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036001946
Quantity per Package
24
Contains DI Package
10705036001942
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |