Identity
- Trade Name
- SAM Splint FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Device Name
- REMOTE MEDICAL 36IN ROLL ORANGE/BLUE FDA UDI
- Model / Reference
- SP526-OB-EN-568 FDA UDI
- Description
- REMOTE MEDICAL 36IN ROLL ORANGE/BLUE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045000698 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- First aid limb splint, mouldable, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: First aid limb splint, mouldable, reusable
SAM Splint by SAM Medical Products — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as First aid limb splint, mouldable, reusable.
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- MedSource Flex-All Splint — MEDSOURCE INTERNATIONAL LLC · Class I
- RISE Splint — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
- ADD-A-SPLINT™ COMPLETE KIT DELUXE — DARCO International, Inc. · Class I
- Dynarex ActiSplint — Dynarex Corp. · 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
- SAM Medical Products
Sources (2)
- FDA UDI 55acad93-831a-4b43-96f2-02688fd00c5e 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026