Duns Number:040876183
Device Description: ArmGuard Rail-Mounted Sled - Secures to OR table rail with slotted rail clamp. Width-adjus ArmGuard Rail-Mounted Sled - Secures to OR table rail with slotted rail clamp. Width-adjustable to add up to 6 in 15.2 cm. For use with ArmGuard Packs and accessories.
Catalog Number
-
Brand Name
ArmGuard™
Version/Model Number
40018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
982a6b48-7475-4682-8053-fcd6d55b1adb
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 17, 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 | 28 |