Identity
- Trade Name
- Turtlebrace FDA UDI
- Generic Name
- Custom-made upper-limb orthosis FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- Wrist Adult with zipper closure FDA UDI
- 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) FDA UDI
Identifiers
- Catalog Number
- TBPAZ-01, TBPAZ-02,TBPAZ-03 FDA UDI
- Primary DI / UDI-DI
- 30628634832098 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Custom-made upper-limb orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made upper-limb orthosis
Turtlebrace by 9321-8758 Québec Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Custom-made upper-limb orthosis.
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- Ambroise — Ambroise Holland B.V. · Class I
- Ambroise — Ambroise Holland B.V. · Class I
- Turtlebrace — 9321-8758 Québec Inc · Class I
- Turtlebrace — 9321-8758 Québec Inc · Class I
- Turtlebrace — 9321-8758 Québec Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 9321-8758 Québec Inc
Sources (1)
- FDA UDI 389e9f67-5277-441b-a276-ba5c10be4ec4 36 fields · synced May 30, 2026