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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 Light-Scope anoscope is a disposable medical device deemed for investigation of the anal canal. The handle has a lodgment for a THD Fiber Optic Cable tip for using the anoscope with a THD light source. The THD Light-Scope anoscope has a flat white end which allows to reflect the light and have a clear and detailed vision of the inspected field. The THD Light-Scope anoscope can be available with truncated or bevelled tip. FDA UDI
- Model / Reference
- THD Light - Scope Bevelled Anoscope Sterile FDA UDI
- Description
- THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal canal. The handle has a lodgment for a THD Fiber Optic Cable tip for using the anoscope with a THD light source. The THD Light-Scope anoscope has a flat white end which allows to reflect the light and have a clear and detailed vision of the inspected field. The THD Light-Scope anoscope can be available with truncated or bevelled tip. FDA UDI
Identifiers
- Catalog Number
- 800114 FDA UDI
- Primary DI / UDI-DI
- 08033737710548 FDA UDI
- FDA Product Code
- FER FDA UDIGCP 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
- Outer Diameter — 22.1 Millimeter FDA UDILength — 90 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 14da7d32-b152-4a14-83d4-fc181dc42daa 36 fields · synced Jun 8, 2026