Identity
- Trade Name
- THD SLIDE ONE FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- THD Slide is specifically designed to be immediately used with the Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD ANOLIFT US kit is a disposable kit containing the following medical devices, each one individually pack withing each kit carton box: - THD Slide - THD Doppler Probe - Sutures (both traditional for ligation and barbed sutures for mucopexy) FDA UDI
- Model / Reference
- THD ANOLIFT US FDA UDI
- Description
- THD Slide is specifically designed to be immediately used with the Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD ANOLIFT US kit is a disposable kit containing the following medical devices, each one individually pack withing each kit carton box: - THD Slide - THD Doppler Probe - Sutures (both traditional for ligation and barbed sutures for mucopexy) FDA UDI
Identifiers
- Catalog Number
- 800330 FDA UDI
- Primary DI / UDI-DI
- 08051887047918 FDA UDI
- 510(k) Number
- K090009 FDA UDI
- FDA Product Code
- JAF FDA UDI
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 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
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
No
FDA UDI
Category: Invasive vascular ultrasound system probeOptical anoscope, single-use
Thd Slide One by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical anoscope, single-use.
- HEINE UniSpec® Disposable Tubes — Heine Optotechnik GmbH & Co. KG · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- ANOSPEC — OBP CORPORATION · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Anoscope — SAPI MED SPA · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Sani-Scope — CooperSurgical, Inc. · Class II
Cleared under the same submission
K090009 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thd Spa
Sources (1)
- FDA UDI bd966bef-ca86-4b08-b9ac-db498b1dfa95 36 fields · synced May 30, 2026