DX-D 45C 55DKA

GUDID 05414904197141

DX-D 45C DETECTOR SET

AGFA

Indirect flat panel x-ray detector

• Primary Device ID: 05414904197141
• NIH Device Record Key: 9ce6899c-f49e-452a-821a-a337cf9ad5e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DX-D 45C
• Version Model Number: 6007/201
• Catalog Number: 55DKA
• 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: false
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05414904197141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142184

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: 6
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

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• 05414904225066 - Mamoray HDR-C Plus: 2022-11-24
• 05414904231678 - Dentus M2 Comfort: 2022-11-24
• 05414904231692 - Dentus M2 Comfort: 2022-11-24
• 05414904231531 - Dentus Ortholux Register: 2022-11-14