FDA UDI
In Commercial Distribution
🇺🇸 United States
Silvalea Boned Back Stand aid poly loops LARGE
DI: 05056387401836
·
Model: 202GL
·
SILVALEA LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silvalea Boned Back Stand aid poly loops LARGE
- Primary DI
- 05056387401836
- Version / Model
- 202GL
- Company Name
- SILVALEA LIMITED
- Labeler DUNS
- 423632996
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-13
- Public Version
- 1
- Public Version Date
- 2025-03-21
- Public Version Status
- New
- Public Device Record Key
- 2b817815-c4f0-4f8a-b17a-e67745843c7a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| INE | Sling, Overhead Suspension, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45382 | Stand-up mobile patient lifting system sling/harness | A lifting device used together with a stand-up mobile lift system to provide a support for an incapacitated patient or a person with a disability that is being lifted from a sitting to a standing position for transfer, (re)positioning and use of a toilet. It is also used to support the patient/person in a standing position to assist in dressing them. It is designed as a sling/harness construction made of straps which is strapped around the person's chest and which will cradle and hold their body during the lifting process. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056387401836 | GS1 |