Duns Number:030200852
Device Description: PLASMABLADE PS210-030S-SP LOCK MPSS
Catalog Number
-
Brand Name
PlasmaBlade™
Version/Model Number
PS210-030S-SP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 08, 2019
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
K093695
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
89f2a035-c53f-4b68-88ea-d8ec12da9fff
Public Version Date
November 22, 2021
Public Version Number
5
DI Record Publish Date
July 09, 2017
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |