Identity
- Trade Name
- Turtlebrace FDA UDI
- Generic Name
- Custom-made lower-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 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), Pediatric (PED) FDA UDI
- Model / Reference
- Ankle Pediatric 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 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), Pediatric (PED) FDA UDI
Identifiers
- Catalog Number
- TBCP-01, TBCP-02,TBCP-03 FDA UDI
- Primary DI / UDI-DI
- 20628634832039 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Custom-made lower-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 lower-limb orthosis
Turtlebrace by 9321-8758 Québec Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made lower-limb orthosis.
- Ambroise — Ambroise Holland B.V. · Class I
- 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
- 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 2d4cba43-c326-4049-94eb-24561bf6d999 36 fields · synced Jun 1, 2026