PCR Eleva 732066

GUDID 00884838074569

System Image Processing, Radiological

Philips Medical Systems DMC GmbH

Computed radiography digital imaging scanner

• Primary Device ID: 00884838074569
• NIH Device Record Key: 02272fcc-3338-4c8d-a8e7-57414a08659e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCR Eleva
• Version Model Number: 9890-010-83831
• Catalog Number: 732066
• 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	00884838074569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093355

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-19

On-Brand Devices [PCR Eleva]

• 00884838074569: System Image Processing, Radiological
• 00884838004047: System Image Processing, Radiological