Identity
- Trade Name
- THD PressProbe FDA UDI
- Generic Name
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
- Device Name
- THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination. FDA UDI
- Model / Reference
- THD PressProbe (Env) FDA UDI
- Description
- THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination. FDA UDI
Identifiers
- Catalog Number
- 800144 FDA UDI
- Primary DI / UDI-DI
- 08033737711286 FDA UDI
- 510(k) Number
- K161785 FDA UDI
- FDA Product Code
- KLA FDA UDI
- GMDN Term
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 165 Millimeter FDA UDIOuter Diameter — 16 Millimeter FDA UDIWeight — 25 Gram FDA UDI
Category: Gastrointestinal motility manometric catheter, non-electronic
THD PressProbe by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161785 also covers:
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
- Thd Spa
Sources (1)
- FDA UDI 476b6e7d-5867-480b-b3d9-3d8ce67f5f67 37 fields · synced May 30, 2026