DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen 1044296

GUDID 60889971044297

CRMAMMO CASSETTE W/EHR M3 SCREEN 24X30

CARESTREAM HEALTH, INC.

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• Primary Device ID: 60889971044297
• NIH Device Record Key: 4fa8b618-7c2d-4154-9502-a73a7e1c8c04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
• Version Model Number: DIRECTVIEW CR Mammography Cassette with EHR-M3 Scr
• Catalog Number: 1044296
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971044297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080018

FDA Product Code

• MUE: Full field digital, system, x-ray, mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-06

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