Duns Number:040729840
Device Description: MICRO NEURO BIOPSY FORCEPS LIGHTWEIGHT GOLFBALL BAYONET HANDLE STRAIGHT 360° ROTATABLE SHA MICRO NEURO BIOPSY FORCEPS LIGHTWEIGHT GOLFBALL BAYONET HANDLE STRAIGHT 360° ROTATABLE SHAFT SQUEEZE HANDLE
Catalog Number
-
Brand Name
MICRO NEURO BIOPSY FORCEPS
Version/Model Number
2900-006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2018
Issuing Agency
In HIBCC
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
HTD
Product Code Name
Forceps
Public Device Record Key
137fdf58-b57f-43d6-ae9f-86638a8e17a8
Public Version Date
August 21, 2019
Public Version Number
7
DI Record Publish Date
August 19, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |