AccessGUDID - DEVICE: THD Procto Software System (68051887043325)

GUDID

Device Identifier (DI) Information

Brand Name: THD Procto Software System
Version or Model: THD DIGITAL MOBILE ADVANCED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800309
Company Name: THD SPA

Primary DI Number: 68051887043325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound. THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.

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

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: e45243ec-a8e4-4814-bde2-0a12a4b6337c
Public Version Date: December 22, 2023
Public Version Number: 1
DI Record Publish Date: December 14, 2023