Duns Number:040876183
Device Description: ArmGuard Bariatric Sled - Sled with extended base for patients wider than OR table. For us ArmGuard Bariatric Sled - Sled with extended base for patients wider than OR table. For use with ArmGuard Packs and Width Extender Packs.
Catalog Number
-
Brand Name
ArmGuard™
Version/Model Number
40240
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
94ac4525-5c5a-45da-8d84-75a9bce77dd5
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 |