FDA UDI
In Commercial Distribution
🇺🇸 United States
NailLift
DI: 04997963005783
·
Model: ML4SF-E
·
JPS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NailLift
- Primary DI
- 04997963005783
- Version / Model
- ML4SF-E
- Company Name
- JPS CORPORATION
- Labeler DUNS
- 696081397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-16
- Public Version
- 1
- Public Version Date
- 2026-03-24
- Public Version Status
- New
- Public Device Record Key
- be7ea920-9fdf-4213-96fa-5fd39eaebac5
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MQZ | Prosthesis, Nail | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63284 | Ingrowing toenail splint/brace | A non-sterile device intended to treat ingrowing toenail and the associated pain by lifting the nail at the outer edges to encourage the nail to grow out naturally. It is in the form of a band and/or wire intended to be applied on the toenail and/or clipped under the edges of the nail. It is made of polymer and/or metallic materials and is usually available [non-prescription] over-the-counter (OTC). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04997963005783 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230841 | 000 |