DigitalDiagnost 712227

GUDID 00884838085688

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

Philips Medical Systems DMC GmbH

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00884838085688
• NIH Device Record Key: ed12607c-e649-4c12-840d-9c3509770d67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigitalDiagnost
• Version Model Number: 9890-010-83904
• Catalog Number: 712227
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838085688 [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: 2018-11-12
• Device Publish Date: 2017-12-11

On-Brand Devices [DigitalDiagnost]

• 00884838085695: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838085688: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838085671: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838074521: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838074514: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838065321: Solid State X-Ray Imager (Flat Panel/Digital Imager)