Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Intrauterine curette, manual FDA UDI
- Device Name
- SIMS UTERINE CURETTE, SHARP, MALLEABLE SHAFT, #5 FDA UDI
- Model / Reference
- G2G37060 FDA UDI
- Description
- SIMS UTERINE CURETTE, SHARP, MALLEABLE SHAFT, #5 FDA UDI
Identifiers
- Catalog Number
- G2G37060 FDA UDI
- Primary DI / UDI-DI
- 00840343723521 FDA UDI
- FDA Product Code
- HCY FDA UDI
- GMDN Term
- Intrauterine curette, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Surgix Medical Llc
Sources (1)
- FDA UDI c46b4364-a19b-40d3-9403-e5f9db5a8980 36 fields · synced Jun 8, 2026