Duns Number:109903521
Device Description: 4.5 ELITE, FULL RADIUS, VALLEYLAB GENERATOR-COMPATIBLE. 4.5 ELITE, FULL RADIUS, VALLEYLAB GENERATOR-COMPATIBLE. COMPATIBLE WITH THE VALLEYLAB, ERBE AND VULCAN WHEN USED WITH THE VULCAN GENERATOR ADAPTER GENERATORS
Catalog Number
7209700
Brand Name
NA
Version/Model Number
7209700
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
c9f8485f-8938-48f1-8e8c-5527432919cf
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
23596010475552
Quantity per Package
3
Contains DI Package
03596010475558
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 |