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 Light-Score LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The Light-Score LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED rectoscope is ready-to-use and it also available with an inflating included FDA UDI
Model / Reference: THD Light - Scope LED Medium Rectoscope with inflation bulb Sterile FDA UDI
Description: The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The Light-Score LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED rectoscope is ready-to-use and it also available with an inflating included FDA UDI

Identifiers

Catalog Number: 800119 FDA UDI
Primary DI / UDI-DI: 08033737710630 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 277e2c85-7b7c-4765-ab05-9f853cfbc494 36 fields · synced May 30, 2026