FDA UDI
In Commercial Distribution
🇺🇸 United States
JETT
DI: 08594201094019
·
Model: JETT PLASMA Medical II
·
COMPEX, spol. s r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JETT
- Primary DI
- 08594201094019
- Version / Model
- JETT PLASMA Medical II
- Company Name
- COMPEX, spol. s r.o.
- Labeler DUNS
- 495080822
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- 9660b804-06e8-4003-b912-2edc1294f682
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QVJ | Low Power Electrosurgical Devices For Skin Lesion Destruction | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45630 | Electrocautery system, line-powered | An assembly of line-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08594201094019 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213247 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius