Cryomold® 4730

GUDID 10615233078787

Biopsy

SAKURA FINETEK U.S.A., INC.

Tissue embedding mould holder IVD

• Primary Device ID: 10615233078787
• NIH Device Record Key: 3664c58c-561d-4a10-829a-8384b9103c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryomold®
• Version Model Number: 4730
• Catalog Number: 4730
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 12
• 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
• 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
• Phone: +1(310)972-7800
• Email: TS@sakuraus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233078780 [Unit of Use]
GS1	10615233078787 [Primary]

FDA Product Code

• KER: Container, Embedding
• MXT: DEVICE, ACCESSORY, COOLING PLATE FOR TISSUE EMBEDDING STATION

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: 2020-03-25
• Device Publish Date: 2020-03-17

On-Brand Devices [Cryomold®]

• 10615233078787: Biopsy
• 10615233078770: Standard