Duns Number:044606982
Device Description: Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use wi Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Generator G11
Catalog Number
HAR36
Brand Name
Harmonic ACE
Version/Model Number
HAR36
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
K120729,K121550,K120729,K121550,K120729,K121550
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
cc2b35fb-454c-49b4-9229-07a76b97343e
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
30705036014441
Quantity per Package
24
Contains DI Package
10705036014447
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 |