Duns Number:484942081
Device Description: Arm Support Lateral 4600-46, VE pad / Arm Board, viscoelastic, 450 mm / Rail clamping ba Arm Support Lateral 4600-46, VE pad / Arm Board, viscoelastic, 450 mm / Rail clamping base 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.
Catalog Number
-
Brand Name
FISSO
Version/Model Number
4646.05
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
d8338dc0-308b-4198-b5e7-779d567c496d
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 30, 2021
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 |