AccessGUDID - DEVICE: THD Procto Software System (58051887042642)

GUDID

Device Identifier (DI) Information

Brand Name: THD Procto Software System
Version or Model: THD HRStation
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800299
Company Name: THD SPA

Primary DI Number: 58051887042642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
KLA	Monitor, Esophageal Motility, And Tube
ITX	Transducer, Ultrasonic, Diagnostic
FWG	Camera, Television, Endoscopic, With Audio
OUG	Medical Device Data System
NSX	Software, Transmission And Storage, Patient Data

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211623	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 363ab120-d4d8-460f-8102-3ef0ac40a440
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022