Duns Number:001191048
Device Description: Davol Advantage Single-Use Quick-Disconnect J-Hook Electrosurgical Attachment with Stick R Davol Advantage Single-Use Quick-Disconnect J-Hook Electrosurgical Attachment with Stick Resistant Tip Coating, 5mm x 33cm
Catalog Number
5600140
Brand Name
Advantage
Version/Model Number
5600140
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
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
ebe6caef-8abc-4d9c-945b-1c15453a2589
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 22, 2016
Package DI Number
10801741077194
Quantity per Package
10
Contains DI Package
00801741077197
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |