Duns Number:484942081
Device Description: FISSO Instrument-holder:Device Table-mounted self-retaining instrument holder system consi FISSO Instrument-holder:Device Table-mounted self-retaining instrument holder system consisting of stainless-steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. All joints are locked in position simultaneously via the adjustment knob located on the central joint. Is intended for the secure, continuously variable clamping of instruments.
Catalog Number
3840.41
Brand Name
FISSO
Version/Model Number
3840.41
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
c6476a94-b4f1-448f-8e9f-c6c4e4b723c1
Public Version Date
October 27, 2021
Public Version Number
2
DI Record Publish Date
July 01, 2019
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |