Duns Number:109903521
Device Description: 4.5 ELITE, VULCAN GENERATOR-COMPATIBLE ELECTROBLADE 4.5 ELITE, VULCAN GENERATOR-COMPATIBLE ELECTROBLADE RESECTORS, MAROON, PACKAGED 3 PER BOX, STERILE
Catalog Number
7209983
Brand Name
NA
Version/Model Number
7209983
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
b77d7b24-5511-4aef-a562-269b990996db
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
23596010492313
Quantity per Package
3
Contains DI Package
03596010492319
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 |