Duns Number:175697908
Device Description: he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
Catalog Number
PB1
Brand Name
PhotonBlade™
Version/Model Number
PB1
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
b5708275-2dfc-4323-aadf-f0721fe4226a
Public Version Date
April 24, 2020
Public Version Number
2
DI Record Publish Date
June 03, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |