Duns Number:041517095
Device Description: The Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the A The Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the Alumi-Hand is ready to go. Made of aluminum, the Alumi-Hand is Lead-Free, Latex-Free, and X-ray compatible.
Catalog Number
760-8 Single
Brand Name
AlumiHand
Version/Model Number
Large
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"
Yes
For Single-Use
Yes
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
d8dde6a5-be73-47dc-8b14-1ce5d5ad0aa5
Public Version Date
July 29, 2020
Public Version Number
1
DI Record Publish Date
July 21, 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 | 162 |