Identity
- Trade Name
- Gynex FDA UDI
- Generic Name
- Endometrial biopsy curette FDA UDI
- Model / Reference
- CSU3900-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNXCSU390050 FDA UDI
- FDA Product Code
- HCY FDA UDI
- GMDN Term
- Endometrial biopsy curette FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endometrial biopsy curette
Gynex by Gynex Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endometrial biopsy curette.
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- Sims Curette — CooperSurgical, Inc. · Class I
- LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) — Uvision360, Inc. · Class II
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
- Gynex Corporation
Sources (1)
- FDA UDI fbb5b521-1199-4a2d-94a4-f440135544cc 32 fields · synced Jun 8, 2026