Duns Number:792528510
Device Description: 5mm 32cm L Hook Monopolar RF Electrode, Baird/Davol style, double insulated with replaceab 5mm 32cm L Hook Monopolar RF Electrode, Baird/Davol style, double insulated with replaceable tip protector sleeve, suction/irrigation with cutting coagulation, for use with Baird/Davol disposable handle
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-52932442
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
-
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
6b5461f3-c629-4cb6-a6c1-6d5da456b519
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |