SkyPlate large

GUDID 00884838084636

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Philips Medical Systems DMC GmbH

Indirect flat panel x-ray detector

• Primary Device ID: 00884838084636
• NIH Device Record Key: 1d10c001-3b37-48a0-9366-e9468062f3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkyPlate large
• Version Model Number: 4598-012-4298.
• Company DUNS: 314101218
• Company Name: Philips Medical Systems DMC GmbH
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838084636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141736

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: 2019-05-07
• Device Publish Date: 2018-12-12

On-Brand Devices [SkyPlate large]

• 00884838084636: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838074705: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838065222: Solid State X-Ray Imager (Flat Panel/Digital Imager)