AccessGUDID - DEVICE: THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope (08033737710340)

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_Sterile
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800004
Company Name: THD SPA

Primary DI Number: 08033737710340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design allows an easy access to the anus, thus a good dilatation and a gentile retraction of the mucosa, without any trauma to the sphincter. The wide lateral slit allows an optimal visualization of the anal canal and enhanced the operative field. THD Surgy anoscope is the ideal device for all the diagnostic and operative needs in proctology, such as assessment and treatment of all proctological conditions, including haemorrhoids, fistulas, condylomas, polyps, low cancers, etc.

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

[?]

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

[?]

Product Code	Product Code Name
GCP	Endoscope, Ac-Powered And Accessories
FER	Anoscope 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: 58ead3ed-b634-4690-bbe7-70bdb69deb1e
Public Version Date: October 28, 2024
Public Version Number: 6
DI Record Publish Date: December 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
38033737710341	3	18033737710347	In Commercial Distribution
18033737710347	8	08033737710340	In Commercial Distribution
28033737710344	20	08033737710340	In Commercial Distribution
48033737710348	10	08033737710340	In Commercial Distribution	Cartoon Box