ProGrade 712090

GUDID 00884838065239

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

Philips Medical Systems DMC GmbH

Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system

• Primary Device ID: 00884838065239
• NIH Device Record Key: 24b41deb-09b3-42ab-9366-0fc2ddc7b584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGrade
• Version Model Number: 9897-010-01041
• Catalog Number: 712090
• 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	00884838065239 [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: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-19

On-Brand Devices [ProGrade]

• 00884838074538: Solid State X-Ray Imager (Flat Panel/Digital Imager)
• 00884838065239: Solid State X-Ray Imager (Flat Panel/Digital Imager)