FDA UDI
In Commercial Distribution
🇺🇸 United States
Ergoline Spirit HLT
DI: EJKP100004083A0
·
Model: JK 191 / 42-3 HLT
·
JK-Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ergoline Spirit HLT
- Primary DI
- EJKP100004083A0
- Version / Model
- JK 191 / 42-3 HLT
- Company Name
- JK-Products GmbH
- Labeler DUNS
- 316232073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-30
- Public Version
- 1
- Public Version Date
- 2025-05-08
- Public Version Status
- New
- Public Device Record Key
- 28423c92-c442-48c6-b96a-0b4be2b00f21
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
- 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
- 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 |
|---|---|---|---|---|
| LEJ | Booth, Sun Tan | General, Plastic Surgery | 878.4635 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46387 | Ultraviolet tanning device | A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EJKP100004083A0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220500 | 000 |