SC

Basic Information

• Brand Name: SC
• Primary DI: 00026072022900
• Version / Model: S530
• Company Name: Allied Medical, LLC
• Labeler DUNS: 119066872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-09
• Public Version: 3
• Public Version Date: 2025-10-13
• Public Version Status: Update
• Public Device Record Key: 9ca187a7-09f4-4786-a5d2-efba65f75c30

Device Description

4 MINI SPLINT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32302	Inflatable extremity splint, reusable	A sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospital. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00026072022900	GS1