Identity
- Trade Name
- Top Shelf Orthopedics FDA UDI
- Generic Name
- Multiple spinal region orthosis FDA UDI
- Device Name
- TLSO Brace EUDAMEDFDA UDI
- Model / Reference
- 510525 EUDAMEDFDA UDI
- Description
- TLSO Brace FDA UDI
Identifiers
- Catalog Number
- 510525 FDA UDI
- Primary DI / UDI-DI
- 00850016589217 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850016589TLSOTFBP EUDAMED
- FDA Product Code
- IPY FDA UDI
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE ORTHOSES EUDAMED
- GMDN Term
- Multiple spinal region orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TLSO Brace by Top Shelf Manufacturing, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850016589TLSOTFBP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Top Shelf Manufacturing, LLC
- EUDAMED SRN
- US-MF-000044418
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED 5b7c7fad-5f4b-45d6-b043-3ce1e9987dc2 61 fields · synced Jul 21, 2026
- FDA UDI c30defb1-5d19-4b68-8eb5-80433fecef9f 35 fields · synced May 30, 2026