FDA UDI
In Commercial Distribution
🇺🇸 United States
Spencer
DI: 08057711232154
·
Model: ST10431B TRANSPORT CHAIR 4BELL SILVER
·
SPENCER ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spencer
- Primary DI
- 08057711232154
- Version / Model
- ST10431B TRANSPORT CHAIR 4BELL SILVER
- Company Name
- SPENCER ITALIA SRL
- Labeler DUNS
- 442102067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 92b6a000-5714-4d3f-a1ce-b6cacff19e8b
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| INM | Chair, With Casters | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41630 | Attendant-only-propelled wheelchair, non-bariatric | A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057711232154 | GS1 |