Duns Number:963249342
Device Description: FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Bla FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade
Catalog Number
FM2121S
Brand Name
FMwand
Version/Model Number
2121S
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
5f5e68ef-6c2c-4cdc-9596-2e88379efdd6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 10, 2016
Package DI Number
20859729006121
Quantity per Package
5
Contains DI Package
10859729006124
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 |