REGIUS Plate

GUDID 04560141931381

KONICA MINOLTA, INC.

Digital imaging storage phosphor screen

• Primary Device ID: 04560141931381
• NIH Device Record Key: ee285e2d-d3a5-45f9-9715-9ad8aa5889b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS Plate
• Version Model Number: ED64
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141931381 [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 Plate]

• 04560141931381: ED64
• 04560141931107: P49C
• 04560141931091: DYEY
• 04560141931084: E264
• 04560141931077: ED7W
• 04560141931060: EDQY
• 04560141931053: EDNQ
• 04560141931046: EDFV
• 04560141931039: EDE3
• 04560141931022: EDDM