HistoCore PEGASUS 14048858005

GUDID 04049188216397

The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS is designed for in vitro diagnostic applications.

Leica Biosystems Nussloch GmbH

Tissue processor IVD, automated

• Primary Device ID: 04049188216397
• NIH Device Record Key: f86652d5-dd68-4a66-8592-36d47860c7b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HistoCore PEGASUS
• Version Model Number: 000000014048858005
• Catalog Number: 14048858005
• Company DUNS: 315539452
• Company Name: Leica Biosystems Nussloch GmbH
• 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: true

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04049188216397 [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: 2021-11-10
• Device Publish Date: 2021-11-02

Devices Manufactured by Leica Biosystems Nussloch GmbH

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• 04049188210784 - ASP6025 S 120V/50-60Hz: 2022-09-16 The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydra
• 04049188210791 - ASP6025 S China: 2022-09-16 The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydra
• 04049188216397 - HistoCore PEGASUS: 2021-11-10The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS is designed for in vitro diagnostic applications.
• 04049188216397 - HistoCore PEGASUS: 2021-11-10 The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with interm
• 04049188217769 - HistoCore PEGASUS Plus: 2021-11-10 The HistoCore PEGASUS Plus is an automated tissue processor specifically designed for fixation, dehydration, infiltration with i
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• 04049188003119 - Leica TP1020 F /accessories: 2019-01-04 The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that
• 04049188041326 - Leica TS5015 - Transfer Station: 2019-01-04 Leica Biosystems Accessory