Identity
- Trade Name
- Symphion Resecting Device FDA UDI
- Generic Name
- Electrolytic-plasma electrosurgical system FDA UDI
- Device Name
- Symphion Operative Hysteroscopy System Resecting Device for use with Symphion Controller FDA UDI
- Model / Reference
- FG-0201 FDA UDI
- Description
- Symphion Operative Hysteroscopy System Resecting Device for use with Symphion Controller FDA UDI
Identifiers
- Catalog Number
- FG-0201 FDA UDI
- Primary DI / UDI-DI
- 00850033976076 FDA UDI
- FDA Product Code
- PGT FDA UDI
- GMDN Term
- Electrolytic-plasma electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1710 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
No
FDA UDI
Category: Electrolytic-plasma electrosurgical system
Symphion Resecting Device by Minerva Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
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- BONSS — Jiangsu Bonss Medical Technology Co., Ltd. · Class II
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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 b78aa0b5-589a-4e33-b493-c8494632fcf2 35 fields · synced May 30, 2026