Identity
- Trade Name
- TULSA-PRO FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- TULSA-PRO TUBE-SET - ULTRASOUND APPLICATOR FDA UDI
- Model / Reference
- 104010 FDA UDI
- Description
- TULSA-PRO TUBE-SET - ULTRASOUND APPLICATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540281001677 FDA UDI
- 510(k) Number
- K191200 FDA UDI
- FDA Product Code
- PLP FDA UDI
- GMDN Term
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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 Conditional FDA UDI
Category: Therapeutic oncological/gynaecological ultrasound system
Tulsa-Pro by Profound Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191200 also covers:
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
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
- Profound Medical Inc
Sources (1)
- FDA UDI bfda23a0-e7fd-4d47-91c7-c9089fbcf627 34 fields · synced Jun 6, 2026