Identity
- Trade Name
- SAM Soft Shell Splint XL FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Device Name
- 9IN SOFT SHELL SPLINT XL FDA UDI
- Model / Reference
- SS541-EN FDA UDI
- Description
- 9IN SOFT SHELL SPLINT XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045428874 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
Category: First aid limb splint, mouldable, reusable
SAM Soft Shell Splint XL by SAM Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid limb splint, mouldable, reusable.
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- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
Sources (1)
- FDA UDI f709b280-4731-4bc8-a152-ebf7b2019f9c 34 fields · synced Jun 8, 2026