Duns Number:044606982
Device Description: Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length Fo Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use With Gray Hand Piece Only
Catalog Number
HARH45
Brand Name
Harmonic ACE
Version/Model Number
HARH45
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
K132612,K132612,K132612,K132612
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
18851a8e-5139-4a57-b048-da1547c352c1
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
40705036014639
Quantity per Package
12
Contains DI Package
10705036014638
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 |