Tissue-Tek Xpress® x50 7760

GUDID 00615233081728

Processing Reagent Set

SAKURA FINETEK U.S.A., INC.

Histology tissue processing reagent kit IVD

• Primary Device ID: 00615233081728
• NIH Device Record Key: 2d4561b3-19dd-46e9-8111-4cdb5c29b369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Xpress® x50
• Version Model Number: 7760
• Catalog Number: 7760
• 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: true
• 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	00615233081728 [Primary]

FDA Product Code

• LDZ: FIXATIVE, ALCOHOL CONTAINING

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

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