DEVICE: RISE Splint (00818630015536)
Device Identifier (DI) Information
RISE Splint
1
In Commercial Distribution
87-1046
TACTICAL MEDICAL SOLUTIONS, LLC
1
In Commercial Distribution
87-1046
TACTICAL MEDICAL SOLUTIONS, LLC
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f378ce9-fb95-455f-b696-95552554089a
May 04, 2021
1
April 26, 2021
May 04, 2021
1
April 26, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00818630015598 | 25 | 00818630015536 | In Commercial Distribution | Pack | |
00818630015604 | 4 | 00818630015598 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
864-224-0081
info@tacmedsolutions.com
info@tacmedsolutions.com