Duns Number:040729840
Device Description: MICRO NEURO NEEDLE HOLDER LARGE GAUGE GOLD KNURLED BAYONET HANDLE STRAIGHT 360° ROTATABLE MICRO NEURO NEEDLE HOLDER LARGE GAUGE GOLD KNURLED BAYONET HANDLE STRAIGHT 360° ROTATABLE SHAFT SQUEEZE HANDLE
Catalog Number
-
Brand Name
MICRO NEURO NEEDLE HOLDER
Version/Model Number
2900-0011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 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
FHQ
Product Code Name
Holder, Needle, Gastroenterologic
Public Device Record Key
4a8a28e5-7dcb-4ef7-9dea-040042a0d904
Public Version Date
January 08, 2021
Public Version Number
6
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 |