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Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA
FDA UDIClass III (US FDA UDI)
by Insightec
Identity
- Trade Name
- Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- Kit for 10 Neuro treatments Kit content: Part Description SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) X 2 units FDA UDI
- Model / Reference
- SET001100 Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA FDA UDI
- Description
- Kit for 10 Neuro treatments Kit content: Part Description SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) X 2 units FDA UDI
Identifiers
- Catalog Number
- SET001100 FDA UDI
- Primary DI / UDI-DI
- 07290015461863 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
Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Therapeutic oncological/gynaecological ultrasound system.
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- TULSA-PRO — Profound Medical Inc · Class II
- TULSA-PRO — Profound Medical Inc · Class II
- TULSA-PRO — Profound Medical Inc · Class II
- TULSA-PRO — Profound Medical Inc · Class II
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 8eb3e9d1-9df5-4c52-b3dd-3f3abdad6ae6 36 fields · synced Jun 6, 2026