Duns Number:787855907
Device Description: Smoke Plume Electrosurgical Pencil, Stainless steel blade
Catalog Number
PLP1001
Brand Name
PlumePen
Version/Model Number
Elite
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
46f3f2ef-1a92-4c95-b159-0250c3ff8e20
Public Version Date
April 22, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
30815198012084
Quantity per Package
4
Contains DI Package
20815198012087
Package Discontinue Date
April 21, 2022
Package Status
Not 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |