SkyPlate large

GUDID 00884838065222

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

Philips Medical Systems DMC GmbH

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 00884838065222
• NIH Device Record Key: 49bfa457-c676-4181-83c4-3c7fc22d58d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkyPlate large
• Version Model Number: 9897-010-00834
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884838065222 [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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-19

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)