DIRECTVIEW CR Mammography Cassette with HR Screen 1717446

GUDID 60889971717443

10SC 18X24CM ESCN HR PHOSPHOR SCR

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic Digital imaging cassette/storage phosphor screen, mammographic

• Primary Device ID: 60889971717443
• NIH Device Record Key: 17fade55-3f0d-4b05-92ce-802ac4349256
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Mammography Cassette with HR Screen
• Version Model Number: DIRECTVIEW CR Mammography Cassette with HR Screen
• Catalog Number: 1717446
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 10
• 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

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	00889971717441 [Unit of Use]
GS1	60889971717443 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [DIRECTVIEW CR Mammography Cassette with HR Screen]

• 60889978364763: DIRECTVIEW CR Mammo Cassett HR Scrn18x24
• 60889971717443: 10SC 18X24CM ESCN HR PHOSPHOR SCR
• 60889971650511: DIRECTVIEW CR Cassett with HR Scrn 24x30