AccessGUDID - DEVICE: NeuralBot Procedural Set (Single Use) (00850681007115)

GUDID

Device Identifier (DI) Information

Brand Name: NeuralBot Procedural Set (Single Use)
Version or Model: 1.x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NA-DSP2
Company Name: Novasignal Corp.

Primary DI Number: 00850681007115
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 078766464 *Terms of Use

Device Description: The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.

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:	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?
63568	Noninvasive vascular ultrasound support kit	A collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
OQQ	Diagnostic Ultrasonic Transducer, Robotic
IYN	System, Imaging, Pulsed Doppler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180455	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: c000d675-321a-4bdb-b446-a50e56e173a6
Public Version Date: August 19, 2022
Public Version Number: 4
DI Record Publish Date: July 26, 2018