FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113681931
·
Model: Tailback 64
·
MANAMED INC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113681931
- Version / Model
- Tailback 64
- Catalog Number
- TB064
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 1
- Public Version Date
- 2022-06-28
- Public Version Status
- New
- Public Device Record Key
- c9ade847-e250-4248-8afb-d7b886207dde
Device Description
The Tailback 64 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, spine motion restriction, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size TLSO Thoracic bar with height adjustments Lightweight, latex-free breathable material Single 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
- No
- 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 |
|---|---|---|---|---|
| IPT | Orthosis, Thoracic | Physical Medicine | 890.3490 | 1 |
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33031 | Lumbar spine orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device. | No | Active |
| 41042 | Thoracic spine orthosis | A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of 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 | 00810113681931 | GS1 |