Identity
- Trade Name
- RISE Splint FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Device Name
- The RISE™ (Rigid Immobilization System for Extremities) is a rugged, low-profile, splint for extremity fractures and pelvic binding in the prehospital environment. Born from lessons on the battlefield, it can be intuitively applied under stress to create a straight splint, 90-degree splint, or pelvic binder. It can be easily secured to the patient with items such as an elastic wrap or pressure bandage. It features dynamic living hinges that allow the splint to collapse for maximum portability and kit space savings while easily form-fitting to the required shape and dimensions for proper upper and lower extremity splinting of fractures. With its compact size, the RISE™ fits into most individual first aid kits including all standard military-issued IFAKs. Unique to the RISE™, multiple cutout slots provide you the capability to create a pelvic binder when paired with a windlass or ratcheting tourniquet such as our new SOF® Tourniquet. The Committee on Tactical Combat Casualty Care (CoTCCC) recognizes splinting and pelvic binding application as a critical step to prevent additional injury before moving a casualty. The one-of-a-kind design is made of a lightweight polymer capable of withstanding surface cleaning and harsh elements, including saltwater while maintaining its rigidity and durability. Whether you’re on the battlefield or a responder here at home, the RISE™ is an advantageous addition to any IFAK for increasing your medical capability at the point of injury when needed most. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The RISE™ (Rigid Immobilization System for Extremities) is a rugged, low-profile, splint for extremity fractures and pelvic binding in the prehospital environment. Born from lessons on the battlefield, it can be intuitively applied under stress to create a straight splint, 90-degree splint, or pelvic binder. It can be easily secured to the patient with items such as an elastic wrap or pressure bandage. It features dynamic living hinges that allow the splint to collapse for maximum portability and kit space savings while easily form-fitting to the required shape and dimensions for proper upper and lower extremity splinting of fractures. With its compact size, the RISE™ fits into most individual first aid kits including all standard military-issued IFAKs. Unique to the RISE™, multiple cutout slots provide you the capability to create a pelvic binder when paired with a windlass or ratcheting tourniquet such as our new SOF® Tourniquet. The Committee on Tactical Combat Casualty Care (CoTCCC) recognizes splinting and pelvic binding application as a critical step to prevent additional injury before moving a casualty. The one-of-a-kind design is made of a lightweight polymer capable of withstanding surface cleaning and harsh elements, including saltwater while maintaining its rigidity and durability. Whether you’re on the battlefield or a responder here at home, the RISE™ is an advantageous addition to any IFAK for increasing your medical capability at the point of injury when needed most. FDA UDI
Identifiers
- Catalog Number
- 87-1046 FDA UDI
- Primary DI / UDI-DI
- 00818630015536 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
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
No
FDA UDI
Category: First aid limb splint, mouldable, reusable
RISE Splint by Tactical Medical Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI 3f378ce9-fb95-455f-b696-95552554089a 35 fields · synced May 30, 2026