FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultra Support Orthopedic Back Brace
DI: 00891237001249
·
Model: 62301-62305
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Ultra Support Orthopedic Back Brace
- Primary DI
- 00891237001249
- Version / Model
- 62301-62305
- Catalog Number
- 1249
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-07
- Public Version
- 1
- Public Version Date
- 2018-09-07
- Public Version Status
- New
- Public Device Record Key
- eb7e4364-2bfb-4922-aee1-0982f24476e9
Device Description
• User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operative rehabilitation, Lumbar instability • The Ultra Support (LSO) Back Brace provides stabilization of the spine and restriction of the pelvis. This, in turn, relieves the pressure on the lumbar discs which helps alleviate pain and increase rehabilitation. • The ergonomic design allows it to be comfortably worn under clothing. • For best fit, download the Sizing Chart below
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
- No
- 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 |
|---|---|---|---|---|
| MRI | Orthosis, Truncal/Orthosis, Limb | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41029 | Lumbosacral spine orthosis, hernia/ptosis support | A cloth orthopaedic corset designed to encompass the lumbosacral spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through abdominal compression, as well as to provide support for abdominopelvic hernias/ptosis. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10891237001246 | GS1 | Outer Carton | 50 | In Commercial Distribution | |
| Primary | 00891237001249 | GS1 |
Customer Contacts
- Phone
- 18009150116
- [email protected]