Point-of-Care CR Cassette with Screen Type A 8284523

GUDID 60889978284528

Point-of-Care CR Cass W SCRN TYP A 35x43

CARESTREAM HEALTH, INC.

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• Primary Device ID: 60889978284528
• NIH Device Record Key: c455c53d-e0de-46ae-abc7-99b89b2e8149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Point-of-Care CR Cassette with Screen Type A
• Version Model Number: Point-of-Care CR Cassette with Screen Type A
• Catalog Number: 8284523
• 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: 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
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• 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	60889978284528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945039

FDA Product Code

• IXA: Cassette, radiographic film

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 [Point-of-Care CR Cassette with Screen Type A]

• 60889978472239: Point-of-Care CR Cass W SCRN TYP A 20x25
• 60889978284528: Point-of-Care CR Cass W SCRN TYP A 35x43
• 60889971880758: Point-of-Care CR Cass W SCRN TYP A 25x30
• 60889971395504: Point-of-Care CR Cass W SCRN TYP A 35x35