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THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDIClass II (US FDA UDI)
by Thd Spa
Identity
- Trade Name
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design allows an easy access to the anus, thus a good dilatation and a gentile retraction of the mucosa, without any trauma to the sphincter. The wide lateral slit allows an optimal visualization of the anal canal and enhanced the operative field. THD Surgy anoscope is the ideal device for all the diagnostic and operative needs in proctology, such as assessment and treatment of all proctological conditions, including haemorrhoids, fistulas, condylomas, polyps, low cancers, etc. FDA UDI
- Model / Reference
- THD Surgy Maxi_Sterile FDA UDI
- Description
- THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design allows an easy access to the anus, thus a good dilatation and a gentile retraction of the mucosa, without any trauma to the sphincter. The wide lateral slit allows an optimal visualization of the anal canal and enhanced the operative field. THD Surgy anoscope is the ideal device for all the diagnostic and operative needs in proctology, such as assessment and treatment of all proctological conditions, including haemorrhoids, fistulas, condylomas, polyps, low cancers, etc. FDA UDI
Identifiers
- Catalog Number
- 800005 FDA UDI
- Primary DI / UDI-DI
- 08033737710333 FDA UDI
- FDA Product Code
- GCP FDA UDIFER FDA UDI
- GMDN Term
- Optical anoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 122.4 Millimeter FDA UDIOuter Diameter — 27.4 Millimeter FDA UDI
Category: Optical anoscope, single-use
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope by Thd Spa — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Optical anoscope, single-use.
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- Bioseal Inc. — BIOSEAL · Class I
- Anoscope — SAPI MED SPA · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Sani-Scope — CooperSurgical, Inc. · Class II
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 22f1f446-7118-4361-afae-ac907f80121d 36 fields · synced May 30, 2026