DIRECTVIEW CR Cassette with PQ Screen 8824609

GUDID 60889978824601

35x43CM DV CR REPLACMT PLATE/PQ SCR

CARESTREAM HEALTH, INC.

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• Primary Device ID: 60889978824601
• NIH Device Record Key: cb626573-bb5a-4a33-b8a6-3fddcf703744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Cassette with PQ Screen
• Version Model Number: DIRECTVIEW CR Cassette with PQ Screen
• Catalog Number: 8824609
• 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
• 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	60889978824601 [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: 5
• Public Version Date: 2019-03-13
• Device Publish Date: 2016-09-16

On-Brand Devices [DIRECTVIEW CR Cassette with PQ Screen]

• 60889978933884: SGL 35X35CM DIRECTVIEW PQ SCR
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• 60889978619108: 10SC 35X43CM DIRECTVIEW PQ SCR
• 60889978604500: 15X30CM DIRECTVIEW PQ SCR
• 60889978448760: SGL 24X30CM DIRECTVIEW PQ SCR
• 60889978294459: 24x30CM DV CR REPLACMT PLATE/PQ SCR
• 60889978104147: 15x30CM DV CR REPLACMT PLATE/PQ SCR
• 60889971933980: 10SC 35X35CM DIRECTVIEW PQ SCR
• 60889971831989: SGL 18X24CM DIRECTVIEW PQ SCR
• 60889971827296: 18x24CM DV CR REPLACMT PLATE/PQ SCR
• 60889971640987: 35x35CM DV CR REPLACMT PLATE/PQ SCR
• 60889971603241: 35X43CM CR CASS/PQ/RIGID 100MICRON
• 60889971600004: 10SC 24X30CM DIRECTVIEW PQ SCR
• 60889971433701: 10SC 15X30CM DIRECTVIEW PQ SCR
• 60889971157539: 10SC 18X24CM DIRECTVIEW PQ SCR
• 60889971089410: SGL 35X43CM DIRECTVIEW PQ SCR
• 60889971031761: 35X35CM CR CASS/PQ/RIGID 100MICRON
• 60889978413515: DIRECTVIEW CR Cassett with PQ Scrn 35x43