FDA UDI
In Commercial Distribution
🇺🇸 United States
Sannio Mesh
DI: 00860006225025
·
Model: 1
·
The Sannio Group Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
40
Basic Information
- Brand Name
- Sannio Mesh
- Primary DI
- 00860006225025
- Version / Model
- 1
- Company Name
- The Sannio Group Inc
- Labeler DUNS
- 117795806
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- 3840803b-050e-4073-b8ec-318c5f5687eb
Device Description
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.
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 10860006225022 | GS1 | Cardboard Case | 4 | In Commercial Distribution | |
| Primary | 00860006225025 | GS1 | ||||
| Unit of Use | 00860006225032 | GS1 |