Duns Number:131480662
Device Description: The RISE™ (Rigid Immobilization System for Extremities) is a rugged, low-profile, splint f 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.
Catalog Number
87-1046
Brand Name
RISE Splint
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NOC
Product Code Name
Splint, Extremity, Non-Inflatable, External, Non-Sterile
Public Device Record Key
3f378ce9-fb95-455f-b696-95552554089a
Public Version Date
May 04, 2021
Public Version Number
1
DI Record Publish Date
April 26, 2021
Package DI Number
00818630015598
Quantity per Package
25
Contains DI Package
00818630015536
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |