Turtlebrace

Basic Information

• Brand Name: Turtlebrace
• Primary DI: 30628634832067
• Version / Model: Ankle Adult Reinforced
• Catalog Number: TBCAR-01, TBCAR-02, TBCAR-03
• Company Name: 9321-8758 Québec Inc
• Labeler DUNS: 203875315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-16
• Public Version: 1
• Public Version Date: 2023-01-24
• Public Version Status: New
• Public Device Record Key: 84aebd63-715d-4541-b914-1b7dbb378b3c

Device Description

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Adult (ADU)

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: Yes
• Has Lot/Batch Number: No
• 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
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66056	Custom-made lower-limb orthosis	An externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the leg and/or feet. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30628634832067	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			ADU S for adult small
Device Size Text, specify			ADU M for adult medium
Device Size Text, specify			ADU L for adult large