EV Screens 8997322

GUDID 60889978997329

EV SCR 1PR 8x10in NF

CARESTREAM HEALTH, INC.

X-ray intensifying screen

• Primary Device ID: 60889978997329
• NIH Device Record Key: 905092ba-b7f6-4ead-af62-86266bcd16c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV Screens
• Version Model Number: EV Screens
• Catalog Number: 8997322
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978997329 [Primary]

FDA Product Code

• EAM: Screen, intensifying, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [EV Screens]

• 60889978997329: EV SCR 1PR 8x10in NF
• 60889978793457: EV SCR 1PR 15x30cm NF
• 60889971791177: EV SCR 1PR 4.88x14.75in hinged
• 60889971539014: EV SCR 1PR 5x12in NF
• 60889971525673: EV SCR 1PR 15x30cm hinged
• 60889971485397: EV SCR 1PR 8X10IN NF
• 60889971015556: EV SCR, 20PR 15x30cm-Panoramic