Identity
- Trade Name
- Gen2 FDA UDI
- Generic Name
- Soft-tissue surgical hook, reusable FDA UDI
- Device Name
- TUMOR HOOK, DOUBLE - STANDARD FDA UDI
- Model / Reference
- G2N7045 FDA UDI
- Description
- TUMOR HOOK, DOUBLE - STANDARD FDA UDI
Identifiers
- Catalog Number
- G2N7045 FDA UDI
- Primary DI / UDI-DI
- G277G2N70450 FDA UDI
- FDA Product Code
- GDG FDA UDI
- GMDN Term
- Soft-tissue surgical hook, reusable 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 e0d61e12-9d71-4d7c-92bb-6812d563baa5 36 fields · synced Jun 8, 2026