Tissue-Tek Xpress® 7115

GUDID 10615233081497

Pre-Processing Solution

SAKURA FINETEK U.S.A., INC.

Histology tissue processing reagent kit IVD

• Primary Device ID: 10615233081497
• NIH Device Record Key: 83b6c072-93f3-4e41-b40f-288bcbf1778e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Xpress®
• Version Model Number: 7115
• Catalog Number: 7115
• 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	00615233081490 [Unit of Use]
GS1	10615233081497 [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

On-Brand Devices [Tissue-Tek Xpress®]

• 10615233081510: Molecular Fixative
• 10615233081503: Pre-Processing Fixative
• 10615233081497: Pre-Processing Solution
• 00615233081568: Processing Reagent Set, Formula 3
• 00615233081483: Processing Reagent Set, Formula 1
• 00615233081704: x50 Rapid Tissue Processor
• 00615233081629: x120 Rapid Tissue Processor
• 00615233081476: Basket Transportation Tray
• 04946433600553: x120 Rapid Tissue Processor
• 04946433600249: x50 Rapid Tissue Processor