PRO PELVIC SPLINT

Basic Information

• Brand Name: PRO PELVIC SPLINT
• Primary DI: M68955110020
• Version / Model: 02
• Catalog Number: 55-110
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-19
• Public Version: 1
• Public Version Date: 2025-02-27
• Public Version Status: New
• Public Device Record Key: 75276dc2-8c73-493c-aed0-27b3c3f96c75

Device Description

PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for the emergency management of suspected pelvic fracture(s).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
HSQ	Belt, Pelvic, Traction	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63255	Pelvic fracture binder, reusable	A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68955110020	HIBCC

Customer Contacts

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