FDA UDI
In Commercial Distribution
🇺🇸 United States
NuFACE
DI: 00810075940213
·
Model: 42082
·
Nuface
Product Codes
0
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NuFACE
- Primary DI
- 00810075940213
- Version / Model
- 42082
- Company Name
- Nuface
- Labeler DUNS
- 023980008
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-19
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- eece8a8c-bcf8-48aa-85b6-c9d57a0753d4
Device Description
Trinity Kit WHITE W/TWR PRO
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45687 | Red-light phototherapy unit, battery-powered | A battery-powered device designed to emit a low-level narrow-band (LLNB) red light in the visible wavelength around 630 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds. This is a hand-held device that may be operated by the patient/user and is suitable for home-use. It may be used to help treat intraoral, nasal, or dermal conditions such as oral ulcers, gingival inflammation, bad breath, allergic rhinitis (hay fever), or nasal congestion. | No | Obsolete |
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810075940213 | GS1 |