Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- HARDY TYPE TRANSSPHENOIDAL CURETTE BAYONET 3MM DN FDA UDI
- Model / Reference
- G2N49305 FDA UDI
- Description
- HARDY TYPE TRANSSPHENOIDAL CURETTE BAYONET 3MM DN FDA UDI
Identifiers
- Catalog Number
- G2N49305 FDA UDI
- Primary DI / UDI-DI
- 00840343725358 FDA UDI
- FDA Product Code
- FZS FDA UDI
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 c3cfcec2-0e30-4fe6-b031-d043a2cc1787 37 fields · synced May 30, 2026