CR MD4.0R GENERAL PLATE E5PU3

GUDID 05414904043257

CR MD4.0R GENERAL PLATE 15CM X 30CM

AGFA

Digital imaging storage phosphor screen

• Primary Device ID: 05414904043257
• NIH Device Record Key: 14853620-61ba-46bb-b063-7be3ed7f5322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR MD4.0R GENERAL PLATE
• Version Model Number: CR MD4.0R GENERAL PLATE 15X30
• Catalog Number: E5PU3
• Company DUNS: 374444883
• Company Name: AGFA
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Dimensions

• Width: 30 Centimeter
• Width: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904043257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141602

FDA Product Code

• 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: 4
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

On-Brand Devices [CR MD4.0R GENERAL PLATE]

• 05414904043295: CR MD4.0R GENERAL PLATE 35CM X 43CM
• 05414904043288: CR MD4.0R GENERAL PLATE 35CM X 35CM
• 05414904043271: CR MD4.0R GENERAL PLATE 24CM X 30CM
• 05414904043264: CR MD4.0R GENERAL PLATE 18CM X 24CM
• 05414904043257: CR MD4.0R GENERAL PLATE 15CM X 30CM