AccessGUDID - DEVICE: NvisionVLE Marking Console with IRIS (00859591006249)

GUDID

Device Identifier (DI) Information

Brand Name: NvisionVLE Marking Console with IRIS
Version or Model: 94301-MI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 94301-MI
Company Name: NINEPOINT MEDICAL, INC.

Primary DI Number: 00859591006249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961880999 *Terms of Use

Device Description: No description.

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?
62326	Endoscopic optical coherence tomography system	An assembly of mains electricity-powered (AC-powered) devices designed to produce microscopic cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract, respiratory tract] during an endoscopic procedure or ex-vivo. It uses optical coherence tomography (OCT) whereby a light beam provides real-time, in-depth, high-resolution imagery by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It consists of a mobile console with display/controls, an endoscopic fibreoptic probe, and a probe inflation device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQQ	System, Imaging, Optical Coherence Tomography (Oct)

FDA Premarket Submission

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

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
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59b079ab-e306-4e5e-8005-73133145d070
Public Version Date: December 10, 2018
Public Version Number: 1
DI Record Publish Date: November 09, 2018