Identity
- Trade Name
- Colibri micro-ENT Scope FDA UDI
- Generic Name
- Rigid video otorhinolaryngoscope FDA UDI
- Device Name
- Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. FDA UDI
- Model / Reference
- ERW-0200 FDA UDI
- Description
- Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. FDA UDI
Identifiers
- Catalog Number
- ERW-0200 FDA UDI
- Primary DI / UDI-DI
- 07290016539226 FDA UDI
- 510(k) Number
- K192305 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid video otorhinolaryngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Angle — 20 degree FDA UDI
Category: Rigid video otorhinolaryngoscope
Colibri micro-ENT Scope by 3nt Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video otorhinolaryngoscope.
- Colibri micro ENT scope — 3nt Medical , Ltd. · Class II
Cleared under the same submission
K192305 also covers:
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
- 3nt Medical , Ltd.
Sources (1)
- FDA UDI d50da817-2a6c-4bfa-a293-fbf77ab3a614 36 fields · synced May 30, 2026