THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

FDA UDI

Class 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: The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The THD Light-Scope rectoscope combines a magnifier lens in the back cap. The handle has a lodgement for a THD Fiber Optic Cable tip for using the rectoscope with a THD light source. The THD Light-Scope rectoscope is ready-to-use and can also be available with an inflation bulb included. FDA UDI
Model / Reference: THD Light-Scope_Rectoscope Medium with inflation bulb_Sterile FDA UDI
Description: The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The THD Light-Scope rectoscope combines a magnifier lens in the back cap. The handle has a lodgement for a THD Fiber Optic Cable tip for using the rectoscope with a THD light source. The THD Light-Scope rectoscope is ready-to-use and can also be available with an inflation bulb included. FDA UDI

Identifiers

Catalog Number: 800121 FDA UDI
Primary DI / UDI-DI: 08033737710562 FDA UDI
FDA Product Code: FER FDA UDI
GCP 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 20 Millimeter FDA UDI
Length — 190 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

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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 II	Pending data

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Manufacturer

Manufacturer: Thd Spa

Sources (1)

FDA UDI 5fcc330f-5145-4f4a-8f03-1e4c517d6dd2 36 fields · synced May 31, 2026