FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hand Piece Internal hygienic, Packaged, CO2RE Intima
DI: 07290109952833
·
Model: AS89734
·
SYNERON MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hand Piece Internal hygienic, Packaged, CO2RE Intima
- Primary DI
- 07290109952833
- Version / Model
- AS89734
- Catalog Number
- AS89734
- Company Name
- SYNERON MEDICAL LTD
- Labeler DUNS
- 532685716
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-11
- Public Version
- 6
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- 879f66fb-722e-4d52-92f2-cbc785385f36
- Distribution End Date
- 2023-10-16
Device Description
Hand Piece Internal hygienic, Packaged, CO2RE Intima
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07290109952833 | GS1 | ||||
| Package | 17290109952830 | GS1 | KT76616 | 5 | Not in Commercial Distribution | 2023-10-16 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181523 | 000 |