Identity
- Trade Name
- Needle Guide FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications. FDA UDI
- Model / Reference
- 02-0027 FDA UDI
- Description
- The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications. FDA UDI
Identifiers
- Catalog Number
- 02-0027-19G FDA UDI
- Primary DI / UDI-DI
- 03760305400062 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical navigation system
Needle Guide by Quantum Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Quantum Surgical
Sources (1)
- FDA UDI bbfc7dc1-5bbf-4631-8e39-b23a918afca4 34 fields · synced May 30, 2026