RISE Splint

Basic Information

• Brand Name: RISE Splint
• Primary DI: 00818630015536
• Version / Model: 1
• Catalog Number: 87-1046
• Company Name: TACTICAL MEDICAL SOLUTIONS, LLC
• Labeler DUNS: 131480662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-26
• Public Version: 1
• Public Version Date: 2021-05-04
• Public Version Status: New
• Public Device Record Key: 3f378ce9-fb95-455f-b696-95552554089a

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63273	First aid limb splint, mouldable, reusable	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818630015536	GS1
Package	00818630015598	GS1	Pack	25	In Commercial Distribution
Package	00818630015604	GS1	Case	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]