Tissue-Tek® TEC™ 6 5110

GUDID 00615233009746

Embedding Console System

SAKURA FINETEK U.S.A., INC.

Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD Tissue embedding unit IVD

• Primary Device ID: 00615233009746
• NIH Device Record Key: 48288b44-07dc-4780-9d00-1072bda2e812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek® TEC™ 6
• Version Model Number: 5110
• Catalog Number: 5110
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233009746 [Primary]

FDA Product Code

• IDW: DISPENSERS, PARAFFIN

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: 2020-08-11
• Device Publish Date: 2020-08-03

On-Brand Devices [Tissue-Tek® TEC™ 6]

• 00615233079640: Foot Pedal Switch
• 00615233079626: 75-Cassette Transfer Tray
• 00615233079459: Plus Cryo Console
• 04946433600515: Cryo Module (Requires connnection to product code 5108 for operation)
• 04946433600508: Embedding Module
• 04946433600492: Plus Cryo Console
• 00615233009746: Embedding Console System