FDA UDI
In Commercial Distribution
🇺🇸 United States
Sannio Aeovis
DI: 00860006225018
·
Model: 1
·
The Sannio Group Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sannio Aeovis
- Primary DI
- 00860006225018
- Version / Model
- 1
- Company Name
- The Sannio Group Inc
- Labeler DUNS
- 117795806
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-01
- Public Version
- 1
- Public Version Date
- 2021-02-09
- Public Version Status
- New
- Public Device Record Key
- 0c4705e7-5cac-4832-a8bc-cd8de13d44b3
Device Description
This stainless steel device is customizable to the patient and provides the framework for Sannio Group mesh. Customization allows the device to work with any hospital bed height and incline, and the device can be adjusted to support the arm at different angles.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 890.3640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46325 | Elevation arm sling | A non-sterile hanging band intended to immobilize an injured arm, that is typically suspended from an overhead support. It is designed to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006225018 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 44 | Inch | |
| Width | 14 | Inch |