DIRECTVIEW CR Gridded Cassette with PQ Screen 8645442

GUDID 60889978645442

DIRECTVIEW CR Cassett with PQ Scrn 35x35

CARESTREAM HEALTH, INC.

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• Primary Device ID: 60889978645442
• NIH Device Record Key: fcc00d4a-b347-43ff-bdc0-8fa1562fa42b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Gridded Cassette with PQ Screen
• Version Model Number: DIRECTVIEW CR Gridded Cassette with PQ Screen
• Catalog Number: 8645442
• 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	40889978645448 [Primary]
GS1	60889978645442 [Package]; Contains: 40889978645448; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• IXJ: Grid, 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 [DIRECTVIEW CR Gridded Cassette with PQ Screen]

• 60889978909889: DIRECTVIEW CR Cassett with PQ Scrn 15x30
• 60889978864812: DIRECTVIEW CR Cassett with PQ Scrn 24x30
• 60889978645442: DIRECTVIEW CR Cassett with PQ Scrn 35x35
• 60889978637683: DIRECTVIEW CR Grid Cass w PQ Scrn 35x43
• 60889971585219: DIRECTVIEW CR Cassett with PQ Scrn 18x24