Identity
- Trade Name
- Tailback2-48 FDA UDI
- Generic Name
- Multiple spinal region orthosis FDA UDI
- Device Name
- The Tailback2-48 is a universal lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a semi rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Dual pulley system FDA UDI
- Model / Reference
- TB048-2 FDA UDI
- Description
- The Tailback2-48 is a universal lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a semi rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Dual pulley system FDA UDI
Identifiers
- Catalog Number
- TB048-2 FDA UDI
- Primary DI / UDI-DI
- 00810113682709 FDA UDI
- FDA Product Code
- IPY FDA UDI
- GMDN Term
- Multiple spinal region orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
Yes
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: Multiple spinal region orthosis
Tailback2-48 by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manamed Llc
Sources (1)
- FDA UDI c2356951-384d-49d1-9ddd-e1a715416f07 35 fields · synced May 31, 2026