Identity
- Trade Name
- DAVIS SISTEMA DI TRAZIONE PEDIATRICO EUDAMEDSpencer FDA UDI
- Generic Name
- First aid limb splint, non-mouldable, reusable FDA UDI
- Model / Reference
- Traction system EUDAMEDSR02020 EUDAMEDSR02020D DAVIS PEDIATRICO SISTEMA DI TRAZIONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057711231508 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771123SISTEMATRAZKU EUDAMED
- Direct Marketing DI
- 08057711231508 EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- First aid limb splint, non-mouldable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Poland 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: First aid limb splint, non-mouldable, reusable
Spencer by Spencer Italia Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as First aid limb splint, non-mouldable, reusable.
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- MedSource Traction Splint — MEDSOURCE INTERNATIONAL LLC · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
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 e913d262-9d13-41b1-9c19-1357797b3557 32 fields · synced Jun 14, 2026
- EUDAMED e0257397-7540-4a52-b7a3-f973c75ae080 61 fields · synced Jun 14, 2026