Identity
- Trade Name
- Ambroise FDA UDI
- Generic Name
- Custom-made upper-limb orthosis FDA UDI
- Device Name
- Arm orthosis elbow wrist FDA UDI
- Model / Reference
- Ambroise Triplemode Armorthosis (ATA) FDA UDI
- Description
- Arm orthosis elbow wrist FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720299427754 FDA UDI
- FDA Product Code
- IRA FDA UDI
- GMDN Term
- Custom-made upper-limb orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made upper-limb orthosis
Ambroise by Ambroise Holland B.V. — 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
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
- Ambroise Holland B.V.
Sources (1)
- FDA UDI 28d13e59-d29a-4f5a-8bdb-416d89711627 33 fields · synced May 30, 2026