Identity
- Trade Name
- Monarch Endoscopy Controller FDA UDI
- Generic Name
- Endoscopic control/video-imaging system FDA UDI
- Device Name
- Monarch Endoscopy Controller FDA UDI
- Model / Reference
- MON-000712 FDA UDI
- Description
- Monarch Endoscopy Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810068810971 FDA UDI
- 510(k) Number
- K243219 FDA UDI
- FDA Product Code
- EOQ FDA UDIJAK FDA UDI
- GMDN Term
- Endoscopic control/video-imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI892.1750 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic control/video-imaging system
Monarch Endoscopy Controller by Auris Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243219 also covers:
- Monarch Platform, Bronchoscopy 4.1, Refurbished — Auris Health, Inc
- Monarch™ Cart Software v4.1.0 — Auris Health, Inc
- Monarch™ Cart Software v4.1.1 — Auris Health, Inc
- Monarch™ Laptop P16 Software v4.1.1 — Auris Health, Inc
- Monarch™ Laptop P17 Software v4.1.0 — Auris Health, Inc
- Monarch™ Laptop P17 Software v4.1.1 — Auris Health, Inc
- Monarch™ Tower Software v4.1.0 — Auris Health, Inc
- Monarch™ Tower Software v4.1.1 — Auris Health, Inc
- Extended Patient Introducer Mount — Auris Health, Inc.
- Monarch Platform, Bronchoscopy 4.1 — Auris Health, Inc.
- Monarch™ Laptop P16 Software v4.1.0 — Auris Health, Inc.
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
- Auris Health, Inc.
Sources (1)
- FDA UDI 2350e74a-e3ce-4373-84df-c4ecef8bb5ea 34 fields · synced Jun 6, 2026