Duns Number:071595540
Device Description: POWER POINT PLUS ELECTROSURGICAL HANDPIECE
Catalog Number
130384
Brand Name
POWER POINT PLUS
Version/Model Number
130384
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2021
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
-
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
K936075,K936075,K936075,K936075
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
7368cebc-92db-4138-bd91-79548f021f9b
Public Version Date
July 15, 2021
Public Version Number
5
DI Record Publish Date
March 08, 2017
Package DI Number
50653405041090
Quantity per Package
10
Contains DI Package
40653405041093
Package Discontinue Date
July 15, 2021
Package Status
Not in Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |