Focal compression plate

GUDID 04547410517040

Compression plate

FUJIFILM CORPORATION

Stationary mammographic x-ray system, digital

• Primary Device ID: 04547410517040
• NIH Device Record Key: ffb62a5a-b690-4084-8863-9eac143d1192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focal compression plate
• Version Model Number: COMP PLATE FOCAL HA USA 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: true
• 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: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx
• Phone: +18002728465
• Email: xxx@xxx.xxx

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410517040 [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: 2023-12-11
• Device Publish Date: 2023-01-10

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