FDA UDI
In Commercial Distribution
🇺🇸 United States
Spencer
DI: 08057711230754
·
Model: SR00111B SED - SPENCER EXTRICATION DEVICE CON SACCA
·
SPENCER ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spencer
- Primary DI
- 08057711230754
- Version / Model
- SR00111B SED - SPENCER EXTRICATION DEVICE CON SACCA
- 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
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- f4abced1-297d-4e06-a2a5-f12cdaca4dfd
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
- No
- 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 |
|---|---|---|---|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13818 | Portable stretcher | A hand-carried device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried. It is typically used to transport a patient from areas inaccessible to conventional ambulance stretchers (e.g., mountain or marine sites, difficult indoor situations such as narrow corridors or extremely steep stairways). The patient may be strapped to the device for security. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057711230754 | GS1 |