FDA UDI
In Commercial Distribution
🇺🇸 United States
ManoFX Right, Extra Large
DI: 00810113683164
·
Model: MANOFX-R-XL
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ManoFX Right, Extra Large
- Primary DI
- 00810113683164
- Version / Model
- MANOFX-R-XL
- Catalog Number
- MANOFX-R-XL
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-17
- Public Version
- 1
- Public Version Date
- 2025-10-27
- Public Version Status
- New
- Public Device Record Key
- 63ca768b-c6dd-48d0-88ea-c09ddaadbb37
Device Description
The ManoFX is a wrist hand finger orthosis. The unique design allows fractures of the hand and finger to be positioned for optimum healing. This innovative approach allows customization of the brace to be configured as a Boxer's fracture splint (ulnar gutter splint), Radial Gutter splint, or a Buddy finger splint (metacarpal fracture brace). This version is our Extra-Large size for people who may not fit in one-size-fits-most orthoses. Features: Malleable aluminum stays Split dorsal stay Soft breathable body Wraparound design for customized fit
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| ILH | Splint, Hand, And Components | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41044 | Wrist/hand/finger stable-position orthosis | An externally applied orthopaedic appliance or apparatus designed to maintain both the transverse and longitudinal arches of the hand, and to hold the thumb in a functional position. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113683164 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]