THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope - The THD anoscope is a disposable medical device - THD SPA

Duns Number:338430324

Device Description: The THD anoscope is a disposable medical device deemed for investigation of the anal canal The THD anoscope is a disposable medical device deemed for investigation of the anal canal.Available with truncated or beveled tip.

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More Product Details

Catalog Number

800021

Brand Name

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

Version/Model Number

Bevelled Anoscope Small (Paediatric) Not 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,K121135

Product Code Details

Product Code

FER

Product Code Name

Anoscope And Accessories

Device Record Status

Public Device Record Key

2097eb00-6a06-4b7f-b433-762691b4b6d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 23, 2016

Additional Identifiers

Package DI Number

28033737710122

Quantity per Package

3

Contains DI Package

18033737710125

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