Duns Number:484942081
Device Description: Rails ClampFor height-adjustable columns Ø 16 mmSteam sterilizable up to 134° CFor rail di Rails ClampFor height-adjustable columns Ø 16 mmSteam sterilizable up to 134° CFor rail dimensions 8-10 mm (w) und 25-35 mm (h)Aluminium base body, plastic knobs
Catalog Number
5.280
Brand Name
FISSO
Version/Model Number
5.280-VE
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
9f49b9e3-4f8b-42cd-8219-3198328a56b4
Public Version Date
October 27, 2021
Public Version Number
2
DI Record Publish Date
July 30, 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 |