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Spencer
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref QS24264Model Immobilization Splints
Identity
- Trade Name
- AIR SPLINT - STECCOBENDA GONFIABILE BRACCIO EUDAMEDSpencer FDA UDI
- Generic Name
- Medical device storage mount FDA UDI
- Model / Reference
- Immobilization Splints EUDAMEDQS24264 EUDAMEDQS24264A AIR SPLINT - STECC. GONFIABILE BRACCIO 64 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057711230907 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771123STECCOBENDE4T EUDAMED
- Direct Marketing DI
- 08057711230907 EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Medical device storage mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Medical device storage mount
Spencer by Spencer Italia Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spencer Italia Srl
Sources (2)
- FDA UDI 2e8d4078-b5e3-46bf-9c5b-a757eaef95d5 32 fields · synced Jul 8, 2026
- EUDAMED 0a5fb760-ee6e-4a7b-9c38-48df94a651f6 61 fields · synced Jul 8, 2026