Tissue-Tek AutoSection® 5010

GUDID 00615233079350

Automated Microtome, High Profile

SAKURA FINETEK U.S.A., INC.

Rotary microtome Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD Rotary microtome IVD

• Primary Device ID: 00615233079350
• NIH Device Record Key: 8641e12b-c024-4f6a-9e28-6fe67fa62e97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek AutoSection®
• Version Model Number: 5010
• Catalog Number: 5010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233079350 [Primary]

FDA Product Code

• IDO: MICROTOME, ROTARY

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: 2020-02-14
• Device Publish Date: 2020-02-06

Devices Manufactured by SAKURA FINETEK U.S.A., INC.

• 00615233011299 - Tissue-Tek Genie®: 2023-11-06 anti-p53 Mouse Monoclonal Antibody [DO-7], 1 RTU cartridge
• 00615233011305 - Tissue-Tek Genie®: 2023-11-06 anti-p53 Mouse Monoclonal Antibody [DO-7], 10 RTU capsules
• 00615233010629 - Genemed®: 2023-10-24 anti-HER2 Rabbit Monoclonal Antibody [EP3], Ready-To-Use, 15 mL
• 00615233011183 - Genemed®: 2023-10-24 anti-PRAME Rabbit Monoclonal Antibody [QR005], Concentrate, 1 mL
• 00615233011190 - Genemed®: 2023-10-24 anti-PRAME Rabbit Monoclonal Antibody [QR005], Ready-To-Use, 15 mL
• 00615233008107 - Tissue-Tek Genie®: 2023-07-25 DAB Cleaning Consumables Kit
• 00615233008510 - Tissue-Tek Genie®: 2023-07-25 anti-OCT.2 Rabbit Monoclonal Antibody [EP284], 10 RTU capsules
• 00615233008527 - Tissue-Tek Genie®: 2023-07-25 anti-OCT.2 Rabbit Monoclonal Antibody [EP284], 1 RTU cartridge