Duns Number:484942081
Device Description: FISSO Varioholder Ø 4.5-12.5 mm (QR)Is intended for the secure, continuously variable clam FISSO Varioholder Ø 4.5-12.5 mm (QR)Is intended for the secure, continuously variable clamping of round instruments.Holder in stainless steel, with lateral opening, for round instruments from Ø4.5mm to Ø/12.5mm,steam sterilizable.Connection: FISSO quick release adapter (QR).
Catalog Number
5.716
Brand Name
FISSO
Version/Model Number
5.716
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
289749e3-2743-46b1-8096-beefb366f3c2
Public Version Date
October 27, 2021
Public Version Number
3
DI Record Publish Date
May 11, 2020
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 |