REGIUS Cassette/Plate

GUDID 04560141925472

KONICA MINOLTA, INC.

Digital imaging cassette/storage phosphor screen

• Primary Device ID: 04560141925472
• NIH Device Record Key: 1b7f16d1-d751-4d75-8192-a19b8ce0650b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS Cassette/Plate
• Version Model Number: BUN2
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141925472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092717

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [REGIUS Cassette/Plate]

• 04560141930964: KCU5
• 04560141930957: KCWQ
• 04560141930940: KC6G
• 04560141930933: KCTC
• 04560141930926: KCSK
• 04560141930919: KCQ0
• 04560141930902: KCMM
• 04560141926141: JFJ8
• 04560141925472: BUN2
• 04560141922792: KCLU
• 04560141922747: KCPJ
• 04560141922730: KCKD