FDA.reportPublic FDA data

AVENIO Millisect Head Assembly

Primary DI
07613336146620
Brand
AVENIO Millisect Head Assembly
Company
Roche Molecular Systems, Inc.
Model
08106550001
Catalog number
08106550001
Published
2020-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336146620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336146620076133361466207613336146620

GMDN Terms#

Term, Definition table
TermDefinition
Slide-mounted-tissue dissection system IVDAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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