Duns Number:484942081
Device Description: Arm support lateral 6600-46 / Rail clamping base Fisso, lateral, for rail dimension 25 x Arm support lateral 6600-46 / Rail clamping base Fisso, lateral, for rail dimension 25 x 10 - 32 x 9 mm / Articulated arm length: 460 mm.The Arm Support is used to position the patient arm during anaesthesia as well as during the initiation and reversal phase of anaesthesia. It must only be used by trained medical personnel capable of judging and controlling any danger to patients. If not the case, the user assumes all responsibility.
Catalog Number
6646.01-10044
Brand Name
FISSO
Version/Model Number
6646.01-10044
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
2bc5f1db-9f53-4f81-adbe-a32d7a153691
Public Version Date
July 12, 2022
Public Version Number
1
DI Record Publish Date
July 04, 2022
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 |