FDA UDI
In Commercial Distribution
🇺🇸 United States
OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
DI: 07290109142968
·
Model: Kit for up to 007-xxxx, 110V
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
- Primary DI
- 07290109142968
- Version / Model
- Kit for up to 007-xxxx, 110V
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 5
- Public Version Date
- 2021-10-18
- Public Version Status
- Update
- Public Device Record Key
- fe80bd62-1368-4cb7-9542-f1db9067bf11
Device Description
Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 17774 | General/multiple surgical solid-state/carbon dioxide laser system | A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109142968 | GS1 | ||||
| Direct Marking | 07290109143903 | GS1 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]