Pelvic Binder

Basic Information

• Brand Name: Pelvic Binder
• Primary DI: B54180030050
• Version / Model: Pelvic Binder, EMS Blue w/traction attachment
• Catalog Number: 8003005
• Company Name: FARETEC, INC.
• Labeler DUNS: 626802540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-16
• Public Version: 1
• Public Version Date: 2023-03-24
• Public Version Status: New
• Public Device Record Key: d9db2d13-c84f-4cda-b254-e0b58826e91b

Device Description

Pelvic Binder, EMS, Blue with traction attachment

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: Yes
• 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
IPW	Orthosis, Sacroiliac, Soft	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	B54180030050	HIBCC

Customer Contacts

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