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OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
FDA UDIClass II (US FDA UDI)
by Lumenis
Identity
- Trade Name
- OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ FDA UDI
- Generic Name
- General/multiple surgical solid-state/carbon dioxide laser system FDA UDI
- Device Name
- Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989 FDA UDI
- Model / Reference
- Kit for 008-xxxx and above, 200V PAL FDA UDI
- Description
- Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109142692 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state/carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical solid-state/carbon dioxide laser system
OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical solid-state/carbon dioxide laser system.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumenis
Sources (1)
- FDA UDI f0d336c4-3e69-4fac-92b5-0b969182a341 34 fields · synced May 30, 2026