Duns Number:109903521
Device Description: 5.5 MM DYONICS BONECUTTER ELECTROBLADE, ORANGE. RESECTO 5.5 MM DYONICS BONECUTTER ELECTROBLADE, ORANGE. RESECTOR COMPATIBLE WITH THE VULCAN GENERATOR REQUIRES THE VULCAN GENERATOR ADAPTER AND ERBE GENERATOR
Catalog Number
7205962
Brand Name
NA
Version/Model Number
7205962
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
K012314,K012314
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
c618d7cd-dfc1-435e-962f-14ac692cb827
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
August 23, 2015
Package DI Number
23596010615514
Quantity per Package
3
Contains DI Package
03596010615510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |