AccessGUDID - DEVICE: THD DIGITAL MINICAM (08051887043286)

GUDID

Device Identifier (DI) Information

Brand Name: THD DIGITAL MINICAM
Version or Model: THD DIGITAL MINICAM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800305
Company Name: THD SPA

Primary DI Number: 08051887043286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: The THD DIGITAL MINICAM is a high-resolution video camera, which allows shooting in HD resolution using THD's N-Ano Digital diagnostic devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface (rev 1.4.00 and later), a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera

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:	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?
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWF	Camera, Television, Endoscopic, Without Audio

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: c359d417-98df-4c95-a074-584f6aeb4a9f
Public Version Date: February 28, 2025
Public Version Number: 1
DI Record Publish Date: February 20, 2025