Identity
- Trade Name
- Genesys HTA System Pedestal FDA UDI
- Generic Name
- Circulating-fluid endometrial-ablation control unit FDA UDI
- Device Name
- IV Pole, Tool Kit FDA UDI
- Model / Reference
- M006580040 FDA UDI
- Description
- IV Pole, Tool Kit FDA UDI
Identifiers
- Catalog Number
- M006580040 FDA UDI
- Primary DI / UDI-DI
- 00850033976205 FDA UDI
- FDA Product Code
- FOX FDA UDI
- GMDN Term
- Circulating-fluid endometrial-ablation control unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6990 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid endometrial-ablation control unit
Genesys HTA System Pedestal by Minerva Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid endometrial-ablation control unit.
- Genesys HTA Control Unit - Refurbished — MINERVA SURGICAL, INC. · Class III
- Genesys HTA Control Unit — MINERVA SURGICAL, INC. · Class III
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 I | Pending data |
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Manufacturer
- Manufacturer
- Minerva Surgical, Inc.
Sources (1)
- FDA UDI 7ea49445-65d6-4af5-b0b2-ff6c0eea5e9f 35 fields · synced May 30, 2026