AccessGUDID - DEVICE: AVENIO Millisect (07613336146644)

GUDID

Device Identifier (DI) Information

Brand Name: AVENIO Millisect
Version or Model: 08106568001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08106568001
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 07613336146644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *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):	No
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?
62866	Slide-mounted-tissue dissection system IVD	An assembly of mains electricity (AC-powered) software-based devices designed to be used in the laboratory for the automated, or remotely-controlled, computer-aided dissection of microscope-slide-mounted tissue specimens under digital image guidance, allowing the user to digitally preselect the target dissection area with high precision. It consists of a high-resolution magnification unit, a robotic arm with an attached disposable milling tip, a remote control unit, and a display screen; excised tissues are suctioned into a sample tube for subsequent histopathology analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: b85533bb-1e89-45b4-aac6-0caf76fff90e
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 2020