BEST BACK

Basic Information

• Brand Name: BEST BACK
• Primary DI: 05391512281502
• Version / Model: 007 size L IRON
• Catalog Number: 007
• Company Name: INDACO SRL
• Labeler DUNS: 338470646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-22
• Public Version: 1
• Public Version Date: 2024-03-01
• Public Version Status: New
• Public Device Record Key: a723cc4a-5621-4142-96b1-b9f97eddb46c

Device Description

Best-Back offers a selection of back supports in a variety of colors and sizes. Do you want to match the chrome on your bike – select the “Iron”. Are you inspired by the orange of your favorite motorcycle brand – select “Orange”. Do you prefer the softer side of pink – select “Lady”. We have a size and a style for everyone! For the realization of this garment, synthetic fibers have been mainly used which make it extremely robust and durable over time. Inside, a particular mesh fabric has been chosen consisting of many small cells that make the band breathable and light. On the outside, on the other hand, high quality Velcro has been used which allows the strap fastening system to hook firmly to the surface. The patented rear laces are made of leatherette with a three-dimensional finish with a carbon fiber effect. Indications Muscle tension or contracture Muscle tear Muscle spasm Muscle weakness Disc hernia

Device Characteristics

• Single Use: No
• 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: 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
IQE	Orthosis, Lumbar	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33031	Lumbar spine orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391512281502	GS1

Customer Contacts

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