ManaMomma Maternity Back Brace
Basic Information
- Brand Name
- ManaMomma Maternity Back Brace
- Primary DI
- 00810113683492
- Version / Model
- MM001
- Catalog Number
- MM001
- 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
- c99c977c-8ed2-4ba9-bb7e-ae4477ad7426
Device Description
ManaMomma is a universal spinal orthosis designed to provide support to patients with the pendulous abdomen. It provides a rigid, comfortable, and easy-to-apply solution for every patient. Designed with the utmost care and precision, the ManaMomma is your perfect companion for a safe and comfortable pregnancy journey. This innovative product is crafted to provide unparalleled protection for your precious little one while ensuring your comfort and ease. Key Features: Fetal Protection: Specifically designed to limit anterior pressure on the fetus, ensuring maximum safety and comfort for both mother and baby. Adjustable Fit: The belt can be easily adjusted throughout your pregnancy, accommodating your growing belly and providing consistent support. Unique Positioning: Uniquely designed to be positioned below the umbilicus, offering optimal support without compromising on comfort. Comfortable Design: Made from soft, breathable materials that are gentle on the skin, ensuring you stay comfortable all day long. Easy to Use: Simple to wear and adjust, making it a hassle-free addition to your daily routine. Experience peace of mind and comfort with our Pregnancy Protection Belt, designed to support you and your baby every step of the way
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 | 00810113683492 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]