FDA UDI
In Commercial Distribution
🇺🇸 United States
Extension Panel - Zynex Pro Hybrid LSO 637
DI: 00810113683072
·
Model: 123238
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Extension Panel - Zynex Pro Hybrid LSO 637
- Primary DI
- 00810113683072
- Version / Model
- 123238
- Catalog Number
- 123238
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 1
- Public Version Date
- 2025-12-03
- Public Version Status
- New
- Public Device Record Key
- 22b9e271-7c0c-4b22-bf32-2143b25f9fdd
Device Description
The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar 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. This device is the extension panel to increase the size of the brace.
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 | 00810113683072 | GS1 |
Customer Contacts
- Phone
- 800-495-6670
- [email protected]