FDA UDI
In Commercial Distribution
🇺🇸 United States
InhwRior
DI: 06978785665032
·
Model: YC-JGYJZQ-003
·
Shenzhen Yuechuan trade Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InhwRior
- Primary DI
- 06978785665032
- Version / Model
- YC-JGYJZQ-003
- Company Name
- Shenzhen Yuechuan trade Co., Ltd.
- Labeler DUNS
- 450549961
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-09
- Public Version
- 1
- Public Version Date
- 2025-07-17
- Public Version Status
- New
- Public Device Record Key
- f13ebd36-5deb-4aaf-9465-6394627afb37
Device Description
This device is designed for application to pincer nails (curled nails) or deformed toenails to alleviate pain and improve nail morphology through biomechanical remodeling.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| ITW | Joint, Ankle, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58944 | Nail fungus treatment kit, medicated | A collection of devices which includes a pharmaceutical intended to be used as a procedure pack for the treatment of fungal infection (onychomycosis) of the fingernail(s) and toenail(s). It includes devices such as a urea ointment, pharmaceutical antifungal (e.g., bifonazole) cream, a plastic nail scraper, and adhesive bandages. The procedure involves gradual softening and subsequent removal of the nail before treating the nail bed by topical application of the antifungal cream. It is normally available for patient/layperson use in the home. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06978785665032 | GS1 |