Elite CR System 8981318

GUDID 60889978981311

Elite CR System W/WP

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 60889978981311
• NIH Device Record Key: 32db3b86-40c1-46d2-89ca-ea40faba7a1c
• Commercial Distribution Discontinuation: 2019-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Elite CR System
• Version Model Number: Elite CR System
• Catalog Number: 8981318
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978981311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020635

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: 9
• Public Version Date: 2020-03-09
• Device Publish Date: 2016-09-16

On-Brand Devices [Elite CR System]

• 60889978981311: Elite CR System W/WP
• 60889971794550: Elite CR System