Van Gogh

Basic Information

• Brand Name: Van Gogh
• Primary DI: 00860012995318
• Version / Model: Sample Holder Box
• Company Name: Aquyre Biosciences Inc.
• Labeler DUNS: 962662206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 1
• Public Version Date: 2025-01-29
• Public Version Status: New
• Public Device Record Key: 0a082b8c-8cfb-4a2b-b63a-56dcdd569fe1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IBM	Microscope, Phase Contrast	Pathology	864.3600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66769	Tissue specimen digital imaging scanner IVD	An assembly of devices designed to be used by healthcare professionals at the point-of-care or in a histopathology laboratory to visualise and obtain microscopic images of morphological structures from an excised tissue specimen, using confocal fluorescence microscopy imaging. It is an electrically-powered, software-operated unit with a specimen scanning surface, a confocal fluorescence microscope, and a user-interface display screen for operation and visualization of the resulting images. It is not intended to make patient contact and allows for the direct examination of the excised tissue specimen without the need for slide preparation of tissue sections onto a microscope slide.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860012995325	GS1
Primary	00860012995318	GS1