← Back to catalogue
Head Frame Set for Type 1.1 Systems FDA/ROW
FDA UDIClass III (US FDA UDI)
by Insightec
Identity
- Trade Name
- Head Frame Set for Type 1.1 Systems FDA/ROW FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- INSIGHTEC-MADE Head Frame Set for Type 1.1 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment FDA UDI
- Model / Reference
- SET400168-BD Head Frame Set for Type 1.1 Systems FDA/ROW FDA UDI
- Description
- INSIGHTEC-MADE Head Frame Set for Type 1.1 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment FDA UDI
Identifiers
- Catalog Number
- SET400168-BD FDA UDI
- Primary DI / UDI-DI
- 07290019402237 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
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
MR Safe FDA UDI
Category: Therapeutic oncological/gynaecological ultrasound system
Head Frame Set for Type 1.1 Systems FDA/ROW by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Therapeutic oncological/gynaecological ultrasound system.
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Insightec
Sources (1)
- FDA UDI d8d562c8-2f66-4b66-a1e4-a70eaf26a0f6 36 fields · synced May 31, 2026