Cyto-Tek® 4310

GUDID 00615233078438

Mailer

SAKURA FINETEK U.S.A., INC.

Specimen container mailer, insulated

• Primary Device ID: 00615233078438
• NIH Device Record Key: bd535d40-4256-4884-8a1b-dcaedff86787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyto-Tek®
• Version Model Number: 4310
• Catalog Number: 4310
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233078438 [Primary]

FDA Product Code

• KDT: CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

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: 2020-01-30
• Device Publish Date: 2020-01-22

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