Duns Number:315304071
Device Description: RF HOLLOW BALL EL. BIPO Ø 2.9MM SL 330MM for endoscopic spine surgery, combinable with VE RF HOLLOW BALL EL. BIPO Ø 2.9MM SL 330MM for endoscopic spine surgery, combinable with VERTEBRIS RF electrode handle 899364X00, for single use
Catalog Number
899364300
Brand Name
NA
Version/Model Number
899364300
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWG
Product Code Name
ENDOSCOPE, NEUROLOGICAL
Public Device Record Key
c397ff70-c2bb-4b1d-a8b9-ce39f50cd40a
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
September 28, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |