FDA UDI
In Commercial Distribution
🇺🇸 United States
NextGen Aesthetics LHR
DI: 00860015460639
·
Model: FG2000-D+
·
T AESTHETICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NextGen Aesthetics LHR
- Primary DI
- 00860015460639
- Version / Model
- FG2000-D+
- Company Name
- T AESTHETICS LLC
- Labeler DUNS
- 104436248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-12
- Public Version
- 1
- Public Version Date
- 2026-03-20
- Public Version Status
- New
- Public Device Record Key
- 0850a0a2-46de-4b12-8fcb-cafa6654f1b4
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35057 | Ethylene oxide analyser | A dedicated electronic instrument used for the qualitative/quantitative analysis of the concentration of ethylene oxide (ETO) in a sample. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860015460639 | GS1 |