Duns Number:117795806
Device Description: This mesh, uses the Aeovis device as a framework, together suspending a patient's arm whil This mesh, uses the Aeovis device as a framework, together suspending a patient's arm while laying in a hospital bed. The mesh is a disposable product and should be changed frequently.
Catalog Number
-
Brand Name
Sannio Mesh
Version/Model Number
1
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILI
Product Code Name
Sling, Arm
Public Device Record Key
3840803b-050e-4073-b8ec-318c5f5687eb
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 2021
Package DI Number
10860006225022
Quantity per Package
4
Contains DI Package
00860006225025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |