AccessGUDID - DEVICE: NvisionVLE Imaging Probe 14mm (00859591006027)

GUDID

Device Identifier (DI) Information

Brand Name: NvisionVLE Imaging Probe 14mm
Version or Model: 95101-14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95101-14
Company Name: NINEPOINT MEDICAL, INC.

Primary DI Number: 00859591006027
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":	Yes
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?
62327	Endoscopic optical coherence tomography system probe	A sterile endoscopic device intended to scan cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract] at a microscopic level. It is a flexible fibreoptic bundle with a rotating distal end designed to emit a light beam whereby real-time, in-depth, high-resolution imagery is produced by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It is inserted through the working channel of an endoscope and may be inflated in situ with an inflator; the proximal end connects to the system’s console. It may also be used ex-vivo. This is a single-use 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 [?]
K143678	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -28 and 50 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: 13f91591-0d1b-480b-9ade-0f8ab8f1ca38
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016