Tissue-Tek ClearFIX® 5996

GUDID 10615233080186

Buffered Formalin Fixative

SAKURA FINETEK U.S.A., INC.

10% Neutral buffered formalin IVD

• Primary Device ID: 10615233080186
• NIH Device Record Key: 00b63f55-d98e-4ee2-aef5-010a7b363b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek ClearFIX®
• Version Model Number: 5996
• Catalog Number: 5996
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 4
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00615233080189 [Unit of Use]
GS1	10615233080186 [Primary]

FDA Product Code

• IFP: FORMALIN, NEUTRAL BUFFERED

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: 2019-12-23
• Device Publish Date: 2019-12-15

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

• 00615233011435 - Tissue-Tek Genie®: 2026-01-05 anti-SALL4 Mouse Monoclonal Antibody [6E3]; RTU, 10 capsules/pack.
• 00615233011442 - Tissue-Tek Genie®: 2026-01-05 anti-SALL4 Mouse Monoclonal Antibody [6E3]; RTU, cartridge containing 250 tests.
• 00615233013996 - Tissue-Tek Genie®: 2026-01-05 anti-TRPS1 Rabbit Monoclonal Antibody [ZR382]; RTU, cartridge containing 250 tests.
• 00615233014009 - Tissue-Tek Genie®: 2026-01-05 anti-TRPS1 Rabbit Monoclonal Antibody [ZR382]; RTU, 10 capsules/pack.
• 00615233014474 - Tissue-Tek Genie®: 2026-01-05 anti-OCT3/4 Mouse Monoclonal Antibody [C-10]; RTU, cartridge containing 250 tests.
• 00615233014481 - Tissue-Tek Genie®: 2026-01-05 anti-OCT3/4 Mouse Monoclonal Antibody [C-10]; RTU, 10 capsules/pack.
• 00615233014559 - Tissue-Tek Genie®: 2026-01-05 anti-INSM1 Rabbit Monoclonal Antibody [ZR395]; RTU, 10 capsules/pack.
• 00615233014566 - Tissue-Tek Genie®: 2026-01-05 anti-INSM1 Rabbit Monoclonal Antibody [ZR395]; RTU, cartridge containing 250 tests.