AccessGUDID - DEVICE: EnVisio (00851674008034)

GUDID

Device Identifier (DI) Information

Brand Name: EnVisio
Version or Model: ENVISIO-SYS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENVISIO-SYS
Company Name: Elucent Medical, Inc.

Primary DI Number: 00851674008034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079322481 *Terms of Use

Device Description: EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display

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?
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEU	Marker, Radiographic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183400	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: 0ec4e1ae-9744-44f2-9714-93ba8d47d400
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: April 15, 2019