FDA UDI
In Commercial Distribution
🇺🇸 United States
Tailback2-50 CureTech
DI: 00810113683546
·
Model: TB050-2-CT
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tailback2-50 CureTech
- Primary DI
- 00810113683546
- Version / Model
- TB050-2-CT
- Catalog Number
- TB050-2-CT
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-03
- Public Version
- 1
- Public Version Date
- 2025-10-13
- Public Version Status
- New
- Public Device Record Key
- fbd060db-9768-4188-94f8-7b5fa801b7db
Device Description
The Tailback2-50 is a universal spinal orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. The Tailback2-50 is an upgrade from the original with a double pulley system to ensure the perfect fit. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66086 | Multiple spinal region orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113683546 | GS1 |
Customer Contacts
- Phone
- 866-284-8872
- [email protected]