Duns Number:963249342
Device Description: FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loo FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop
Catalog Number
FM2301S
Brand Name
FMwand
Version/Model Number
2301S
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
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
K140384,K140384,K140384
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f1ab93fa-c48b-4c41-a967-1b0c5f72162a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 10, 2016
Package DI Number
20859729006138
Quantity per Package
5
Contains DI Package
10859729006131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |