AccessGUDID - DEVICE: AVENIO Millisect Tip Large (07613336146606)

GUDID

Device Identifier (DI) Information

Brand Name: AVENIO Millisect Tip Large
Version or Model: 08106525001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 08106525001
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 07613336146606
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2020
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:	Yes
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?
62867	Slide-mounted-tissue dissection system excision tip IVD	A small cutting instrument designed to be mounted on the robotic arm of a digital-image-guided dissection system to excise its microscope-slide-mounted tissue specimens. It is a precision cutting mill bit which is also capable of dispensing dissecting buffer solution and aspirating the excised specimens. This is a single-use device.	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: a417bef6-074b-4fa7-af50-9400def901d5
Public Version Date: November 27, 2020
Public Version Number: 2
DI Record Publish Date: April 30, 2020