THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope - The Light-Score LED rectoscope is a disposable - THD SPA

Duns Number:338430324

Device Description: The Light-Score LED rectoscope is a disposable medical device deemed for investigation of 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.

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More Product Details

Catalog Number

800117

Brand Name

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

Version/Model Number

THD Light - Scope LED Medium Rectoscope Sterile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121135,K121135

Product Code Details

Product Code

FER

Product Code Name

Anoscope And Accessories

Device Record Status

Public Device Record Key

895bfdb2-db11-4b2b-9d47-9a12cf1ebecb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 23, 2016

Additional Identifiers

Package DI Number

18033737710613

Quantity per Package

10

Contains DI Package

08033737710616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"THD SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 53