Duns Number:044606982
Device Description: HARMONIC HD 1000i Shears, 20cm Shaft Length
Catalog Number
HARHD20
Brand Name
Harmonic
Version/Model Number
HARHD20
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
aca3edc1-16b7-4e78-887e-2ac3e20145bf
Public Version Date
October 28, 2021
Public Version Number
6
DI Record Publish Date
August 26, 2016
Package DI Number
20705036015045
Quantity per Package
6
Contains DI Package
10705036015048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |