Identity
- Trade Name
- Neuro Kit 3T for USA FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- Kit for single use during a Neuro treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY MPR000444 HEAD RING SCREWS LONG SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000933 EXABLATE NEURO CLEANING KIT SET400187 NEURO TREATMENT ACCESSORIES KIT FDA UDI
- Model / Reference
- Neuro Kit 3T for USA FDA UDI
- Description
- Kit for single use during a Neuro treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY MPR000444 HEAD RING SCREWS LONG SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000933 EXABLATE NEURO CLEANING KIT SET400187 NEURO TREATMENT ACCESSORIES KIT FDA UDI
Identifiers
- Catalog Number
- SET000936 FDA UDI
- Primary DI / UDI-DI
- 07290015461122 FDA UDI
- FDA Product Code
- POH FDA UDI
- GMDN Term
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Therapeutic oncological/gynaecological ultrasound system
Neuro Kit 3T for USA by Insightec — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Insightec
Sources (1)
- FDA UDI e49ee66f-acda-46ad-9e2c-623fa08e4161 36 fields · synced May 30, 2026