Turtlebrace

Basic Information

• Brand Name: Turtlebrace
• Primary DI: 30628634832098
• Version / Model: Wrist Adult with zipper closure
• Catalog Number: TBPAZ-01, TBPAZ-02,TBPAZ-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: 389e9f67-5277-441b-a276-ba5c10be4ec4

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 a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with zipper closure. 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
66055	Custom-made upper-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 arm and/or hand. 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	30628634832098	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