Pelvic Binder

Basic Information

• Brand Name: Pelvic Binder
• Primary DI: B911PED4X300
• Version / Model: PED4x30
• Catalog Number: PED4x30
• Company Name: Pelvicbinder, Inc
• Labeler DUNS: 127609332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-27
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: ed2a6cc7-f1bf-4e7a-8f88-eae83c64733f

Device Description

Pediatric Yellow Pelvic Binder. Soft goods medical brace for stabilization of fractured pelvis used by physicians in emergency room and paramedics in the pre-hospital environment.

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: MR Safe
• 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
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63496	Pelvic fracture binder, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B911PED4X300	HIBCC

Customer Contacts

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