Duns Number:058614483
Device Description: Curved Jaw Cordless Ultrasonic Dissector
Catalog Number
-
Brand Name
Sonicision 7
Version/Model Number
SCD7A39
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"
Yes
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
K212301,K212301
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
1db66d52-dfe4-4838-85cc-71f3dd06dbc4
Public Version Date
July 08, 2022
Public Version Number
2
DI Record Publish Date
April 25, 2022
Package DI Number
20884521794792
Quantity per Package
6
Contains DI Package
10884521794795
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |