D.B.S. Dynamic Brace System

Basic Information

• Brand Name: D.B.S. Dynamic Brace System
• Primary DI: 07290015711302
• Version / Model: DBS1
• Company Name: MEDITRAC LTD.
• Labeler DUNS: 514587369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-25
• Public Version: 1
• Public Version Date: 2022-08-02
• Public Version Status: New
• Public Device Record Key: 2dd1b5bd-c42e-4696-bf8b-5f8b502ace14

Device Description

The DBS (Dynamic Brace System) is an accessory to the Vertetrac, intended for the treatment of scoliosis. Idiopathic scoliosis (juvenile, adolescent, or adult)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
KQZ	Component, Traction, Non-Invasive	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61214	Wearable lumbar spine traction device	An externally-worn orthopaedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. It consists of adjustable components worn superiorly under the rib cage, and inferiorly over the iliac crests, with rods holding the components apart that can be adjusted to apply traction forces by separation. It may include an additional attachable component intended for the treatment of scoliosis. It is intended for use in the home or a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290015711302	GS1