Identity
- Trade Name
- Symphion 6.3 Hysteroscope FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller Contents: (1) Hysteroscope (1) Storz Scope Adapter (1) Wolf Scope Adapter (1) Working Channel Brush (1) Fluid Channel Brush FDA UDI
- Model / Reference
- FG-0703 FDA UDI
- Description
- Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller Contents: (1) Hysteroscope (1) Storz Scope Adapter (1) Wolf Scope Adapter (1) Working Channel Brush (1) Fluid Channel Brush FDA UDI
Identifiers
- Catalog Number
- FG-0703 FDA UDI
- Primary DI / UDI-DI
- 00850033976120 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Yes
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
Yes
FDA UDI
Category: Rigid optical hysteroscope
Symphion 6.3 Hysteroscope by Minerva Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Minerva Surgical, Inc.
Sources (1)
- FDA UDI b6392260-3c43-4563-8dda-8eb1a65fa251 36 fields · synced Jun 6, 2026