OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
GUDID 07290109142968
Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989
LUMENIS LTD.
General/multiple surgical solid-state/carbon dioxide laser system| Primary Device ID | 07290109142968 |
| NIH Device Record Key | fe80bd62-1368-4cb7-9542-f1db9067bf11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ |
| Version Model Number | Kit for up to 007-xxxx, 110V |
| Company DUNS | 600166524 |
| Company Name | LUMENIS LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109142968 [Primary] |
| GS1 | 07290109143903 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151331
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
[07290109142968]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2016-09-19 |
On-Brand Devices [OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ ]
| 07290109142968 | Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07 |
| 07290109142692 | Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07 |
Trademark Results [OtoScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OTOSCAN 90624141 not registered Live/Pending |
PhotoniCare, Inc. 2021-04-05 |
 OTOSCAN 87356052 not registered Dead/Abandoned |
NeuroLogica Corp. 2017-03-02 |
 OTOSCAN 85752771 4479769 Live/Registered |
GN Otometrics A/S 2012-10-12 |
 OTOSCAN 85716306 not registered Dead/Abandoned |
3DM Systems Acquisition, LLC 2012-08-29 |
 OTOSCAN 74633921 1961203 Dead/Cancelled |
STARKEY LABORATORIES, INC. 1995-01-24 |
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