FDA UDI
In Commercial Distribution
🇺🇸 United States
MedArt Intenz
DI: 05700002070609
·
Model: MedArt 620
·
Medart A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MedArt Intenz
- Primary DI
- 05700002070609
- Version / Model
- MedArt 620
- Catalog Number
- 620.000
- Company Name
- Medart A/S
- Labeler DUNS
- 305130079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-21
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- d92c61ce-70aa-47fb-9f18-31d41fa461e8
Device Description
Medical CO2 laser system for soft tissue treatments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 61473 | Dermatological carbon dioxide laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700002070609 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120573 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 20 | Kilogram | |
| Height | 20 | Centimeter | |
| Length | 60 | Centimeter | |
| Depth | 45 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity