Identity
- Trade Name
- Medistim QuickFIT TTFM probe FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Model / Reference
- PS100052 FDA UDI
Identifiers
- Catalog Number
- PS100052 FDA UDI
- Primary DI / UDI-DI
- 07070554100832 FDA UDI
- 510(k) Number
- K992305 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Invasive vascular ultrasound system probe
Medistim QuickFIT TTFM probe by Medi-Stim Asa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Invasive vascular ultrasound system probe.
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- Pencil probe — Koven Technology, Inc. · Class II
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Cleared under the same submission
K992305 also covers:
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim QuickFIT TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
- Medistim Vascular TTFM probe — Medi-Stim Asa
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
- Medi-Stim Asa
Sources (1)
- FDA UDI a723bb56-951b-4135-a62b-93584ed87164 34 fields · synced May 30, 2026