Identity
- Trade Name
- Turtlebrace FDA UDI
- Generic Name
- Custom-made upper-limb orthosis FDA UDI
- Device Name
- This is a finger add-on for the Turtlebrace wrist brace. It can also be used as a toe extension for the Turtlebrace ankle brace. It 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 add-on is fused to the brace and then can be molded directly to the patient, to immobilize one or more fingers, 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 Universal FDA UDI
- Model / Reference
- Universal Fingers Attachement FDA UDI
- Description
- This is a finger add-on for the Turtlebrace wrist brace. It can also be used as a toe extension for the Turtlebrace ankle brace. It 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 add-on is fused to the brace and then can be molded directly to the patient, to immobilize one or more fingers, 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 Universal FDA UDI
Identifiers
- Catalog Number
- EDUA FDA UDI
- Primary DI / UDI-DI
- 80628634832116 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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- 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 347108ae-10a5-4a4e-b6b1-e1c64b1dcf66 36 fields · synced Jun 8, 2026