Identity
- Trade Name
- SAM® Splint EUDAMEDSAM Splint FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Device Name
- SAM® Splint EUDAMEDSAM SPLINT 36IN ROLL ORANGE/BLUE FDA UDI
- Model / Reference
- SP506-OB-EN EUDAMEDFDA UDI
- Description
- SAM SPLINT 36IN ROLL ORANGE/BLUE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045428669 EUDAMEDFDA UDI
- Basic UDI-DI
- 0822045SP01US EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- First aid limb splint, mouldable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Category: Cotton wool roll, sterile
SAM® Splint by SAM Medical Products — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0822045SP01US | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 467689e7-2612-47f7-bc10-722c241ea821 61 fields · synced Jun 8, 2026
- FDA UDI dd7aa448-0151-47ea-a7f8-1a977e06e35a 34 fields · synced May 29, 2026