HistoCore PEARL 14049350667

GUDID 04049188198907

The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in seque

Leica Biosystems Nussloch GmbH

Tissue processor IVD, automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated Tissue processor IVD, automated/semi-automated

• Primary Device ID: 04049188198907
• NIH Device Record Key: 9e5b6114-3709-496a-a0b1-ead483e048a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HistoCore PEARL
• Version Model Number: 000000014049350667
• Catalog Number: 14049350667
• 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

Customer Support Contacts

• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.co
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com

Device Dimensions

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• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049188198907 [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: 2019-01-04
• Device Publish Date: 2018-12-04

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: 2021-11-10 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
• 04049188003102 - Leica TP1020 VF/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
• 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