Identity
- Trade Name
- neuro cleaning kit for USA FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- single use kit for cleaning the product after a neuro clinical treatment FDA UDI
- Model / Reference
- neuro cleaning kit for USA FDA UDI
- Description
- single use kit for cleaning the product after a neuro clinical treatment FDA UDI
Identifiers
- Catalog Number
- SET000933 FDA UDI
- Primary DI / UDI-DI
- 07290015461160 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 cleaning kit for USA 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 4b114d92-96d3-45ac-8f5e-d3846439c9e6 36 fields · synced May 30, 2026