FDA UDI
In Commercial Distribution
🇺🇸 United States
Edge
DI: 08800020104014
·
Model: Edge
·
Jeisys Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Edge
- Primary DI
- 08800020104014
- Version / Model
- Edge
- Company Name
- Jeisys Medical Inc.
- Labeler DUNS
- 690275362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-03
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 7f04dc25-182e-468d-b08b-b8ca78aafca0
Device Description
CO2 Fractional laser system
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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | 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 |
|---|---|---|---|---|---|---|
| Package | 8800020104038 | GS1 | Wooden crate | 1 | In Commercial Distribution | |
| Primary | 08800020104014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100590 | 000 |