DIRECTVIEW CR Long-Length Imaging System 1307123

GUDID 60889971307125

DIRECTVIEW CR LONG-LENGTH IMAGING SYSTEM

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 60889971307125
• NIH Device Record Key: 4e65d33a-ade6-4d19-b8e8-9aa9172f256c
• Commercial Distribution Discontinuation: 2018-04-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DIRECTVIEW CR Long-Length Imaging System
• Version Model Number: DIRECTVIEW CR Long-Length Imaging System
• Catalog Number: 1307123
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971307125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021829

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: 8
• Public Version Date: 2019-11-25
• Device Publish Date: 2016-09-16

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