AccessGUDID - DEVICE: THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope (08033737710647)

GUDID

Device Identifier (DI) Information

Brand Name: THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version or Model: THD Surgy Mini Light - Scope Sterile
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800124
Company Name: THD SPA

Primary DI Number: 08033737710647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: The THD SURGY light-scope anoscope is a sterile and disposable medical device deemed for investigation of the anal canal. The THD SURGY light-scope anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The THD SURGY light-scope anoscope is ready-to-use and does not need for other tools.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44914	Optical anoscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.	Active	false

FDA Product Code

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Product Code	Product Code Name
FER	Anoscope And Accessories
GCP	Endoscope, Ac-Powered And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 122.4 Millimeter
Outer Diameter: 24 Millimeter

Device Record Status

Public Device Record Key: 7dd78290-b4a6-4f3e-8b93-a67a9e163fd0
Public Version Date: October 28, 2024
Public Version Number: 6
DI Record Publish Date: October 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
28033737710641	3	18033737710644	In Commercial Distribution
18033737710644	8	08033737710647	In Commercial Distribution
38033737710648	10	08033737710647	In Commercial Distribution	Cartoon Box