Identity
- Trade Name
- THD DIGITAL MINICAM FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- The THD DIGITAL MINICAM is a high-resolution video camera, which allows shooting in HD resolution using THD's N-Ano Digital diagnostic devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface (rev 1.4.00 and later), a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera FDA UDI
- Model / Reference
- THD DIGITAL MINICAM FDA UDI
- Description
- The THD DIGITAL MINICAM is a high-resolution video camera, which allows shooting in HD resolution using THD's N-Ano Digital diagnostic devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface (rev 1.4.00 and later), a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera FDA UDI
Identifiers
- Catalog Number
- 800305 FDA UDI
- Primary DI / UDI-DI
- 08051887043286 FDA UDI
- FDA Product Code
- FWF FDA UDI
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope video camera
Thd Digital Minicam by Thd Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Thd Spa
Sources (1)
- FDA UDI c359d417-98df-4c95-a074-584f6aeb4a9f 35 fields · synced May 31, 2026