Duns Number:058614483
Device Description: Energy Platform
Catalog Number
ForceTriad ZD
Brand Name
ForceTriad
Version/Model Number
ForceTriad ZD
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
-
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
K110268
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
d5bd2137-5d84-4085-8829-8d3b67af1702
Public Version Date
April 01, 2020
Public Version Number
2
DI Record Publish Date
December 07, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |