FUJI IMAGING PLATE 47410-17712

GUDID 14547410177128

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.

FUJIFILM CORPORATION

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• Primary Device ID: 14547410177128
• NIH Device Record Key: c519c798-0c37-49b7-a0ef-21d9420a7c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUJI IMAGING PLATE
• Version Model Number: IP-6 HR 24X30CM 2 M E
• Catalog Number: 47410-17712
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• Device Count: 2
• 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: +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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410177121 [Primary]
GS1	14547410177128 [Package]; Contains: 04547410177121; Package: box [20 Units]; In Commercial Distribution
GS1	84547410177127 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862414

FDA Product Code

• EAM: Screen, Intensifying, Radiographic
• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-23

On-Brand Devices [FUJI IMAGING PLATE]

• 14547410177128: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410177111: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410149453: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059431: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059424: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059356: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059349: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059332: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059325: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059318: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen,bo
• 14547410059301: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen,bo
• 14547410059295: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059288: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059271: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b
• 14547410059011: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, b