AccessGUDID - DEVICE: Visura TEECAD Carrier Control Unit (00860226002536)

GUDID

Device Identifier (DI) Information

Brand Name: Visura TEECAD Carrier Control Unit
Version or Model: VS-V2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VIS0101
Company Name: VISURA TECHNOLOGIES, INC.

Primary DI Number: 00860226002536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117057841 *Terms of Use
Previous DI: 00860226002512

Device Description: Visura TEECAD Carrier Control Unit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40786	Ultrasound imaging transducer positioning unit	A unit used to position an ultrasound system imaging transducer that is inserted into the body through an endoscope. This device is an accessory to a diagnostic ultrasound imaging system and it transmits electrical signals that, after processing, will display the position of a the transducer on a monitor. This unit will assist the endoscopist in the placement of the working transducer (the probe) and to allow monitoring of the movement after placement.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180911	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: aa69e9cf-f3c7-456c-9326-12bfb0cec6e7
Public Version Date: August 03, 2022
Public Version Number: 1
DI Record Publish Date: July 26, 2022