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 a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize an elbow 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. Size small (01), medium (02), or large (03) for Adult (ADU) FDA UDI
- Model / Reference
- Elbow Adult FDA UDI
- Description
- The brace is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize an elbow 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. Size small (01), medium (02), or large (03) for Adult (ADU) FDA UDI
Identifiers
- Catalog Number
- TBCoA-01, TBCoA-02, TBCoA-03 FDA UDI
- Primary DI / UDI-DI
- 30628634832180 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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- 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 54327301-5955-4513-beab-7c71b9a99c13 36 fields · synced Jun 6, 2026