HistoCore PELORIS 49.0005

GUDID 09349458004811

The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Tissue processor IVD, automated

• Primary Device ID: 09349458004811
• NIH Device Record Key: 79aa1687-b357-4828-b74b-8775ea0e3bbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HistoCore PELORIS
• Version Model Number: HistoCore PELORIS 3 (100-120V)
• Catalog Number: 49.0005
• Company DUNS: 753184944
• Company Name: LEICA BIOSYSTEMS MELBOURNE PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349458004811 [Primary]

FDA Product Code

• IEO: Processor, Tissue, Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [HistoCore PELORIS]

• 09349458005566: The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection tag
• 09349458005559: A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the
• 09349458004743: Accepts most common cassette types and includes configurable dividers that allow for different c
• 09349458004736: Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure c
• 09349458004729: Accepts most common cassette types and includes configurable dividers that allow for different c
• 09349458004712: Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure c
• 09349458004811: The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue sampl
• 09349458005580: HistoCore PELORIS 3 Win10 Upgrade Kit
• 09349458005573: HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit