Eviva® spacer

GUDID 04547410266078

To use the Eviva needle, attach this spacer between the needle holder M and the Eviva adapter.

FUJIFILM CORPORATION

Stationary mammographic x-ray system, digital

• Primary Device ID: 04547410266078
• NIH Device Record Key: 2ec070bb-8318-4236-8ad9-7fedba554ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eviva® spacer
• Version Model Number: NEEDLE HOLDER H EV E
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410266078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133972

FDA Product Code

• MUE: Full field digital,system,x-ray,mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

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• 04547410484793 - FDR D-EVO III G43i: 2025-09-08 The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which
• 04547410484809 - FDR D-EVO III C35i: 2025-09-08 The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a
• 04547410484816 - FDR D-EVO III C43i: 2025-09-08 The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a
• 04547410484823 - FDR D-EVO III C25i: 2025-09-08 The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a
• 04547410511673 - FDR D-EVO III G80i: 2025-09-08 The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a genera
• 04547410515176 - DR-ID 1200MC: 2025-09-08 Control software (DR-ID 1200MC) can perform correction processing according to the characteristics of Flat panel sensor (DR-ID18